Standard Aseptic Packaging

Standard Aseptic Packaging, Total:71 items.

The international standard classification for "Standard Aseptic Packaging" includes: Packaging materials and accessories , Industrial automation systems , sterilized packaging .

The Chinese standard classification for "Standard Aseptic Packaging" includes: Packaging material and container , Public medical equipment , General and microsurgical devices .

Group Standards of the People's Republic of China

T/CAMDI 009-2018 Sterile Medical Device Package - Part 1： Test Methods for Particulate Matter
T/ZZB 1885-2020 Aluminium-Plastic laminate bags for aseptic packaging of liquid food
T/SDCA 025-2021 Taishan Quality-Liquidpackagingboard（aseptic/white back）
T/CPF 0009-2020 Plastic laminated film using for aseptic packaging
T/SHMHZQ 043-2022 Liquid aseptic flexible packaging machine
T/CAMDI 009.10-2020 Cleanliness of primary package for sterile medical device - Part 10：limits of contamination
T/CNFIA 178-2023 Evaluation criteria for environmental friendliness of aseptic paper-based composite packaging for liquid foods
T/CAMDI 015-2018 Good Manufacturing Practice for Primary Packaging of Sterile Medical Devices

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

GB 18192-2000 Parer based laminated material using for aseptic package of liquid food
GB 18454-2001 Laminated bags using for aseptic package of liquid food
GB/T 19633.1-2015 Packaging for terminally sterilized medical devices―Part 1:Requirements for materials, sterile barrier systems and packaging systems
GB/T 18192-2008 Paper based laminated material using for aseptic packaging of liquid food
GB/T 19633.1-2024 Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems and packaging systems

Professional Standard - Medicine

YY/T 0681.3-2010 Test methods for sterile medical device package—Part 3:Internal pressurization failure resistance of unrestrained packages

未注明发布机构

DIN EN ISO 11607-1 Berichtigung 1:2016 Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems
DIN EN ISO 11607-1 E:2017-11 Packaging of medical devices to be sterilized in final packaging Part 1: Requirements for materials, sterile barrier systems and packaging systems (draft)
DIN ISO 21881 E:2018-08 Sterile packaged ready for filling glass cartridges
DIN ISO 21882 E:2018-08 Sterile packaged ready for filling glass vials
ANSI/AAMI/ISO 11607-1:2019 Packaging for terminally sterilized medical devices— Part 1: Requirements for materials, sterile barrier systems and packaging systems
DIN ISO 11040-7 E:2019-10 Prefilled syringes - Part 7: Packaging systems for sterilized subassembled syringes ready for filling

Professional Standard - Commodity Inspection

SN/T 2567-2010 Asepsis detection for food and packages

Sichuan Provincial Standard of the People's Republic of China

DB510422/T 024-2010 Packaging Standard for Pollution-free Tomatoes

国家市场监督管理总局、中国国家标准化管理委员会

GB/T 18454-2019 Laminated bags for aseptic packaging of liquid food

中华人民共和国国家质量监督检验检疫总局

GB/T 18454-2001 Laminated bags using for aseptic package of liquid food

HU-MSZT

MSZ 486/2-1981 Sterile packaging

IT-UNI

UNI ISO 21882:2021 Sterile packaged ready for filling glass vials
UNI ISO 21881:2021 Sterile packaged ready for filling glass cartridges

American Society for Testing and Materials (ASTM)

ASTM F1980-99e1 Standard Guide for Accelerated Aging of Sterile Medical Device Packages
ASTM F1980-21 Standard Guide for Accelerated Aging of Sterile Medical Device Packages
ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
ASTM F1980-02 Standard Guide for Accelerated Aging of Sterile Medical Device Packages

SCC

NS 4300:1973 Health service - Overwraps for sterile packages
DIN ISO 21882 E:2018 Draft Document - Sterile packaged ready for filling vials (ISO/DIS 21882:2018); Text in German and English
DANSK DS/ISO 21882:2019 Sterile packaged ready for filling glass vials
AS 1079.1:1981 Packaging of items (sterile) for patient care - Guide to selection of packaging materials for goods undergoing sterilization
DANSK DS/ISO 21881:2019 Sterile packaged ready for filling glass cartridges
AS 1079.2:1983 Packaging of items (sterile) for patient care - Paper for the wrapping of goods undergoing sterilization
BS EN ISO 11607-1:2009+A1:2014 Packaging for terminally sterilized medical devices-Requirements for materials, sterile barrier systems and packaging systems
DANSK DS/ISO 11607-1:2020 Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems

NO-SN

NS 4300-1973 Health service - Overwraps for sterile packages

International Organization for Standardization (ISO)

ISO 21882:2019 Sterile packaged ready for filling glass vials
ISO 21881:2019 Sterile packaged ready for filling glass cartridges
ISO 11607:1997 Packaging for terminally sterilized medical devices
ISO 11607:2003 Packaging for terminally sterilized medical devices
ISO 21881:2019/CD Amd 1:2011 Sterile packaged ready for filling glass cartridges
ISO 11607-1:2006/Amd 1:2014 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems; Amendment 1
ISO 11040-7:2024 Prefilled syringes — Part 7: Packaging systems for sterilized subassembled syringes ready for filling

German Institute for Standardization

DIN ISO 21882:2020-12 Sterile packaged ready for filling glass vials (ISO 21882:2019)
DIN ISO 21881:2020-12 Sterile packaged ready for filling glass cartridges (ISO 21881:2019)
DIN ISO 21882:2020 Sterile packaged ready for filling glass vials (ISO 21882:2019)
DIN ISO 21881:2020 Sterile packaged ready for filling glass cartridges (ISO 21881:2019)
DIN EN ISO 11607-1:2020-05 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019); German version EN ISO 11607-1:2020 / Note: To be amended by DIN EN ISO 11607-1/A1 (2022-08).
DIN EN ISO 11607-1/A11:2022-08 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019); German version EN ISO 11607-1:2020/A11:2022

British Standards Institution (BSI)

BS ISO 21882:2019 Sterile packaged ready for filling glass vials
BS EN ISO 11607-1:2009 Packaging for terminally sterilized medical devices - Requirements for materials, sterile barrier systems and packaging systems
BS ISO 21881:2019 Sterile packaged ready for filling glass cartridges
BS EN ISO 11607-1:2020+A1:2023 Packaging for terminally sterilized medical devices - Requirements for materials, sterile barrier systems and packaging systems

ZA-SANS

SANS 305:2007 Winged infusion sets (sterile-packed for single use)
SANS 327:2007 Over-needle peripheral catheters (sterile-packed for single use)
SANS 1918:2007 Needleless connectors (sterile-packed for single patient use)
SANS 348:2006 Safety surgical scalpels, sterile packed for single-use

Korean Agency for Technology and Standards (KATS)

KS P ISO 11607-1:2007 Packaging for terminally sterilized medical devices-Part 1:Requirements for materials, sterile barrier systems, and packaging systems
KS P ISO 11607-1:2021 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems

Association Francaise de Normalisation

NF S98-052-1/A1:2014 Packaging for terminally sterilized medical devices - Part 1 : requirements for materials, sterile barrier systems and packaging systems - Amendment 1

GSO

GSO ISO 11607-1:2021 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
BH GSO ISO 11607-1:2022 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems

Defense Logistics Agency

DLA MIL-P-36744-1971 SURGICAL PACK, DISPOSABLE, PREOPERATIVE PREPARATION, NONSTERILE

KR-KS

KS P ISO 11040-7-2018(2023) Prefilled syringes ─ Part7: Packaging systems for sterilized subassembled syringes ready for filling
KS P ISO 11607-1-2021 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems

ES-UNE

UNE-EN ISO 11607-1:2020 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)

Danish Standards Foundation

DS/EN ISO 11607-1:2009 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems