Non-terminal sterilization methods for medical devices

Non-terminal sterilization methods for medical devices, Total:174 items.

The international standard classification for "Non-terminal sterilization methods for medical devices" includes: Sterilization and disinfection , Sterilization and disinfection in general .

The Chinese standard classification for "Non-terminal sterilization methods for medical devices" includes: Medical apparatus and devices in general , Public medical equipment , General and microsurgical devices .

General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China

GB/T 19633-2005 Packaging for terminally sterilized medical devices

Professional Standard - Medicine

YY/T 0698.8-2009 Packaging materials for terminally sterilized medical devices—Part 8:Re-usable sterilization containers for steam sterilizers—Requirements and test methods
YY/T 0615.1-2007 Requirements for medical devices to be designated STERILE - Part 1: Requirements for terminally sterilized medical devices
YY/T 0698.4-2009 Packaging materials for terminal sterilized medical devices—Part 4:Paper bags—Requirements and test methods
YY/T 0698.6-2009 Packaging materials for terminal sterilized medical devices - Part 6: Paper for manufacture of sterile barrier systems intended for sterilization by low temperature sterilization pro
YY/T 0698.2-2009 Packaging materials for terminal sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods

国家药监局

YY/T 0698.2-2022 Packaging materials for final sterilized medical devices-Part 2: Requirements and test methods for sterilized packaging materials

未注明发布机构

DIN EN 868-2 E:2015-08 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
DIN EN 868-6 E:2015-08 Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
DIN EN 868-4 E:2015-08 Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
DIN EN 868-9 E:2017-08 Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods
CAN/CSA-ISO/TS 16775:2017 Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2

Group Standards of the People's Republic of China

T/CAMDI 058-2020 Packaging for terminally sterilized medical devices—Guidance on the application of GB/T 19633.1 and GB/T 19633.2

国家食品药品监督管理局

YY/T 1607-2018 Radiation sterilization of medical device—Method of dose setting

Korean Agency for Technology and Standards (KATS)

KS P ISO 11607-2007 Packaging for terminally sterilized medical devices
KS P ISO 11607:2007 Packaging for terminally sterilized medical devices
KS P ISO 11607:2002 Packaging for terminally sterilized medical devices

SCC

AAMI 11607:1997 Packaging for terminally sterilized medical devices
DANSK DS/EN 556-1/AC:2006 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
NS-EN 868-2:2017 Packaging for terminally sterilized medical devices — Part 2: Sterilization wrap — Requirements and test methods
UNE-EN 868-2:2009 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
DANSK DS/EN 868-2:2017 Packaging for terminally sterilized medical devices – Part 2: Sterilization wrap – Requirements and test methods
AENOR UNE-EN 556-1:2002 Sterilization of medical products. Requirements for medical devices to be designated "STERILE". Part 1: Requirements for sterilized medical devices in their terminal state.
NS-EN 556-1:2001 Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 1: Requirements for terminally sterilized medical devices
NS-EN 556-1:2024 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
DANSK DS/EN 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
AAMI/ISO 11607:2000 Packaging for terminally sterilized medical devices
UNE-EN 868-6:2009 Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
DIN EN 868-2 E:2015 Draft Document - Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods; German and English version prEN 868-2:2015
DANSK DS/EN 868-6:2017 Packaging for terminally sterilized medical devices – Part 6: Paper for low temperature sterilization processes – Requirements and test methods
NS-EN 868-6:2017 Packaging for terminally sterilized medical devices — Part 6: Paper for low temperature sterilization processes — Requirements and test methods
DANSK DS/ISO/TS 22421:2021 Sterilization of health care products – Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
BS EN 556:1995 Sterilization of medical devices. Requirements for terminally-sterilized devices to be labelled 'Sterile'
NS-EN 868-4:2017 Packaging for terminally sterilized medical devices — Part 4: Paper bags — Requirements and test methods
DANSK DS/EN 868-4:2017 Packaging for terminally sterilized medical devices – Part 4: Paper bags – Requirements and test methods
AENOR UNE-EN 868-4:2017 Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
UNE-EN 868-4:2009 Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
NS-EN 556:1994+A1:1998 Sterilization of medical devices — Requirements for terminally-sterilized medical devices to be labelled "Sterile" (including amendment A1:1998)
DIN EN 556-1 E:2023 Draft Document - Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; German and English version prEN 556-1:2023
DANSK DS/EN 868-10:2019 Packaging for terminally sterilized medical devices – Part 10: Adhesive coated nonwoven materials of polyolefines – Requirements and test methods
AENOR UNE-EN 868-10:2009 Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods
DIN EN 868-6 E:2015 Draft Document - Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods; German and English version prEN 868-6:2015
NS-EN 868-9:2018 Packaging for terminally sterilized medical devices — Part 9: Uncoated nonwoven materials of polyolefines — Requirements and test methods
CSA ISO/TS 16775:2023 Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2
NS-EN 868-8:2018 Packaging for terminally sterilized medical devices — Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 — Requirements and test methods
NS-EN 868-7:2017 Packaging for terminally sterilized medical devices — Part 7: Adhesive coated paper for low temperature sterilization processes — Requirements and test methods
AENOR UNE-EN 868-7:2017 Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
UNE-EN 868-7:2009 Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
DANSK DS/EN 868-7:2017 Packaging for terminally sterilized medical devices – Part 7: Adhesive coated paper for low temperature sterilization processes – Requirements and test methods
AENOR UNE-EN 868-8:2009 Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
DANSK DS/EN 868-8:2019 Packaging for terminally sterilized medical devices – Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 – Requirements and test methods
AENOR UNE-EN 868-9:2009 Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods
DIN EN 868-4 E:2015 Draft Document - Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods; German and English version prEN 868-4:2015
DANSK DS/EN 868-9:2019 Packaging for terminally sterilized medical devices – Part 9: Uncoated nonwoven materials of polyolefines – Requirements and test methods
DANSK DS/CEN ISO/TS 16775:2014 Packaging for terminally sterilized medical devices – Guidance on the application of ISO 11607-1 and ISO 11607-2
AAMI/ISO TIR16775:2014 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
DIN EN 868-8 E:2017 Draft Document - Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods; German and English version prEN 868-8:2017
DIN EN 868-9 E:2017 Draft Document - Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods; German and English version prEN 868-9:2017
NS-EN 13824:2004 Sterilization of medical devices — Aseptic processing of liquid medical devices — Requirements
NS-EN 868-10:2018 Packaging for terminally sterilized medical devices — Part 10: Adhesive coated nonwoven materials of polyolefines — Requirements and test methods
UNE-EN 13824:2005 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
DIN EN 868-10 E:2017 Draft Document - Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods; Version allemande et anglaise prEN 868-10:2017
BS EN ISO 11607-1:2009+A1:2014 Packaging for terminally sterilized medical devices-Requirements for materials, sterile barrier systems and packaging systems
NS-EN 556:1994 Sterilization of medical devices — Requirements for medical devices to be labelled "Sterile"
BS EN ISO 11607-2:2006+A1:2014 Packaging for terminally sterilized medical devices-Validation requirements for forming, sealing and assembly processes
DIN EN 868-7 E:2015 Draft Document - Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods; German and English version prEN 868-7:2015

British Standards Institution (BSI)

PD ISO/TS 22421:2021 Sterilization of health care products. Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
BS EN 868-2:2009 Packaging for terminally sterilized medical devices - Sterilization wrap - Requirements and test methods
BS EN 868-2:2017 Packaging for terminally sterilized medical devices. Sterilization wrap. Requirements and test methods
BS EN 556-1:2001(2006) Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 1 : Requirements for terminally sterilized medical devices
BS EN 868-4:2009 Packaging for terminally sterilized medical devices - Paper bags - Requirements and test methods
BS EN 868-4:2017 Packaging for terminally sterilized medical devices. Paper bags. Requirements and test methods
23/30457243 DC BS EN 556-1. Sterilization of medical devices. Requirements for medical devices to be designated "STERILE" - Part 1. Requirements for terminally sterilized medical devices
BS EN 868-6:2009 Packaging for terminally sterilized medical devices - Paper for low temperature sterilization processes - Requirements and test methods
BS EN 556-1:2024 Sterilization of medical devices. Requirements for medical devices to be designated "STERILE" - Requirements for terminally sterilized medical devices
BS EN 868-9:2009 Packaging for terminally sterilized medical devices - Uncoated nonwoven materials of polyolefines - Requirements and test methods
BS EN 868-6:2017 Packaging for terminally sterilized medical devices. Paper for low temperature sterilization processes. Requirements and test methods
24/30479649 DC BS EN 868-2 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
BS EN 868-8:2018 Packaging for terminally sterilized medical devices. Re-usable sterilization containers for steam sterilizers conforming to EN 285. Requirements and test methods
BS EN 868-10:2009 Packaging for terminally sterilized medical devices - Adhesive coated nonwoven materials of polyolefines - Requirements and test methods
BS EN 868-9:2018 Packaging for terminally sterilized medical devices. Uncoated nonwoven materials of polyolefines. Requirements and test methods
BS EN 868-8:2009 Packaging for terminally sterilized medical devices - Re-usable sterilization containers for steam sterilizers conforming to EN 285: Requirements and test methods
BS EN 868-7:2017 Packaging for terminally sterilized medical devices. Adhesive coated paper for low temperature sterilization processes. Requirements and test methods
24/30479640 DC BS EN 868-6 Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
BS EN 868-10:2018 Packaging for terminally sterilized medical devices. Adhesive coated nonwoven materials of polyolefines. Requirements and test methods
24/30479643 DC BS EN 868-4 Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
20/30408621 DC BS 6256. Packaging for terminally-sterilized medical devices. Method for determination of methylene blue particulate penetration
PD CEN ISO/TS 16775:2021 Packaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2
BS EN ISO 11607-1:2020+A1:2023 Packaging for terminally sterilized medical devices - Requirements for materials, sterile barrier systems and packaging systems
BS PD ISO/TS 22421:2021 Sterilization of health care products. Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
BS EN 868-7:2009 Packaging for terminally sterilized medical devices - Adhesive coated paper for low temperature sterilization processes - Requirements and test methods

ES-UNE

UNE-EN 556-1:2002/AC:2007 Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE' - Part 1: Requirements for terminally sterilized medical devices
UNE-EN 868-10:2019 Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods
UNE-EN 868-9:2019 Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods

Danish Standards Foundation

DS/EN 556-1/AC:2006 Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 1: Requirements for terminally sterilized medical devices
DS/EN 556-1:2002 Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 1: Requirements for terminally sterilized medical devices
DS/EN 868-2:2009 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
DS/ISO/TS 22421:2021 Sterilization of health care products – Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
DS/EN 868-4:2009 Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
DS/EN 868-6:2009 Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
DS/EN 868-7:2009 Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
DS/EN 868-8:2009 Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
DS/EN 868-9:2009 Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods
DS/EN 868-10:2009 Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods

Lithuanian Standards Office

LST EN 556-1-2002/AC-2006 Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE' - Part 1: Requirements for terminally sterilized medical devices
LST EN 556-1-2002 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
LST EN 868-2-2009 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
LST EN 868-4-2009 Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
LST EN 868-6-2009 Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
LST EN 868-7-2009 Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
LST EN 868-8-2009 Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
LST EN 868-9-2009 Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods
LST EN 868-10-2009 Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods

Association Francaise de Normalisation

XP ISO/TS 22421:2021 Sterilization of healthcare products - Common requirements for sterilizers used for terminal sterilization of medical devices in healthcare settings
NF EN 556-1:2002 Stérilisation des dispositifs médicaux - Exigences relatives aux dispositifs médicaux en vue d'obtenir l'étiquetage STERILE - Partie 1 : exigences relatives aux dispositifs médicaux stérilisés au stade terminal
NF EN 868-2:2017 Packaging for terminally sterilized medical devices - Part 2: sterilization envelope - Requirements and test methods
NF S98-051-2*NF EN 868-2:2017 Packaging for terminally sterilized medical devices - Part 2 : sterilization wrap - Requirements and test methods
NF EN 868-6:2017 Packaging for terminally sterilized medical devices - Part 6: paper for low temperature sterilization processes - Requirements and test methods
NF EN 868-4:2017 Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 4 : sacs en papier - Exigences et méthodes d'essai
XP S98-224*XP ISO/TS 22421:2021 Sterilization of health care products - Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
NF S98-051-6*NF EN 868-6:2017 Packaging for terminally sterilized medical devices - Part 6 : paper for low temperature sterilization processes - Requirements and test methods
NF S98-051-4*NF EN 868-4:2017 Packaging for terminally sterilized medical devices - Part 4 : paper bags - Requirements and test methods
NF S98-051-7*NF EN 868-7:2017 Packaging for terminally sterilized medical devices - Part 7 : adhesive coated paper for low temperature sterilization processes - Requirements and test methods
NF S98-051-8*NF EN 868-8:2018 Packaging for terminally sterilized medical devices - Part 8 : re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
NF EN 868-8:2018 Packaging for terminally sterilized medical devices - Part 8: reusable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
NF S98-051-9*NF EN 868-9:2018 Packaging for terminally sterilized medical devices - Part 9 : uncoated nonwoven materials of polyolefines - Requirements and test methods
NF EN 868-7:2017 Packaging for terminally sterilized medical devices - Part 7: adhesive-coated paper for low temperature sterilization processes - Requirements and test methods
XP CEN ISO/TS 16775:2021 Packaging for terminally sterilized medical devices - Guidelines for the application of ISO 11607-1 and ISO 11607-2
XP S98-167*XP CEN ISO/TS 16775:2021 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
NF EN 868-3:2017 Packaging for terminally sterilized medical devices - Part 3: paper used in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of sachets and sheaths (specified in EN 868-5) - Requirement...
NF S98-105:1994 Sterilization of medical devices. Validation and routine control of sterilization by moist heat.
NF S98-051-10*NF EN 868-10:2018 Packaging for terminally sterilized medical devices - Part 10 : adhesive coated nonwoven materials of polyolefines - Requirements and test methods

AENOR

UNE-EN 556-1:2002 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
UNE-EN 868-2:2017 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
UNE-EN 868-4:2017 Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
UNE-EN 868-6:2017 Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
UNE-EN 868-7:2017 Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
UNE-EN 868-8:2009 Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
UNE-EN 868-9:2009 Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods
UNE-EN 868-10:2009 Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods

German Institute for Standardization

DIN EN 556-1 Berichtigung 1:2006-12 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; German version EN 556-1:2001, Corrigenda to DIN EN 556-1:2002-03; German version EN 556-1...
DIN EN 556-1:2002-03 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; German version EN 556-1:2001 / Note: To be replaced by DIN EN 556-1 (2023-02).
DIN EN 556-1:2023-02 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; German and English version prEN 556-1:2023 / Note: Date of issue 2023-01-06*Intended as r...
DIN EN 868-2:2017-05 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods; German version EN 868-2:2017
DIN EN 556-1:2024 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
DIN EN 868-6:2017-05 Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods; German version EN 868-6:2017
DIN EN 868-4:2017-05 Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods; German version EN 868-4:2017
DIN EN 868-10:2019-03 Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods; German version EN 868-10:2018
DIN EN 868-8:2019 Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
DIN EN 868-8:2019-03 Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods; German version EN 868-8:2018
DIN EN 868-7:2017-05 Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods; German version EN 868-7:2017
DIN EN 868-9:2019-03 Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods; German version EN 868-9:2018
DIN EN 868-9:2019 Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods
DIN EN 868-3:2017-05 Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods; German version EN ...
DIN EN 868-10:2019 Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods
DIN EN 868-6:2017 Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods; German version EN 868-6:2017

GSO

BH GSO ISO/TS 22421:2023 Sterilization of health care products — Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
GSO ISO/TS 22421:2023 Sterilization of health care products — Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
OS GSO ISO/TS 16775:2015 Packaging for terminally sterilized medical devices -- Guidance on the application of ISO 11607-1 and ISO 11607-2

KR-KS

KS P ISO 11607-2002 Packaging for terminally sterilized medical devices

RU-GOST R

GOST EN 556-1-2011 Sterilization of medical devices. Requirements for medical devices to be designated «sterile». Part 1. Requirements for terminally sterilized medical devices

American National Standards Institute （ANSI)

AAMI TIR22:1998 Guidance for ANSI/AAMI/ISO 11607, Packaging for terminally sterilized medical devices, 1ed
AAMI/ISO TIR16775:2023 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2

European Committee for Standardization (CEN)

EN 556:1998 Sterilization of Medical Devices - Requirements for Terminally - Sterilized Medical Devices to Be Labelled "Sterile" Ratified European Text; Includes Amendment 1: 1994
EN 868-6:2017 Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
EN 868-4:2017 Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
EN ISO/TS 16775:2014 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
EN 868-2:2017 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
EN 556:1994 Sterilization of Medical Devices - Requirements for Medical Devices to Be Labelled `Sterile'

GOSTR

GOST R 58162-2018 Packaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2

US-AAMI

ANSI/AAMI/ISO TIR16775:2014 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2

CEN - European Committee for Standardization

EN 13824:2004 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements

DIN

DIN EN 13824:2005 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements

TH-TISI

TIS 2278-2006 Sterilization of medical devices-information to be provided by the manufacturer for the processing of resterilizable medical devices

Others: