Efficient Medical Device Testing

Efficient Medical Device Testing, Total:200 items.

The international standard classification for "Efficient Medical Device Testing" includes: Medical equipment in general , Medical equipment , Laboratory medicine .

The Chinese standard classification for "Efficient Medical Device Testing" includes: Medical apparatus and devices in general , Public medical equipment .

Professional Standard - Medicine

YY/T 0802-2020 Processing of medical devices—Information to be provided by the medical device manufacturer
YY/T 0316-2003 Medical devices -- Application of risk management to medical devices
YY/T 0802.2-2024 Disposal of medical devices - Information to be provided by the medical device manufacturer - Part 2: Low-risk medical devices
YY/T 1454-2016 General requirements for in vitro diagnostic medical devices for self-testing
YY/T 0316-2016 Medical devices-Application of risk management to medical devices
YY/T 0802.1-2024 Disposal of medical devices Information to be provided by the medical device manufacturer Part 1: Medium and high risk medical devices
YY/T 0316-2008 Medical devices - Application of risk management to medical devices
YY/T 1474-2016 Medical devices－Application of risk management to medical devices

Group Standards of the People's Republic of China

T/ZMDS 40003-2022 Medical Device Software Verification for Testing

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

GB/Z 42217-2022 Medical device —Validation of software for medical device quality system
GB/T 42062-2022 Medical devices—Application of risk management to medical devices

Jiangsu Provincial Standard of the People's Republic of China

DB32/T 4271-2022 Medical device clean room (area) inspection specification

Professional Standard - Commodity Inspection

SN/T 1430.1-2004 Rules for the inspection of medical electrical equipment for improt - Ultrasonic medical diagnostic and therapy equipment

British Standards Institution (BSI)

DD ISO/TS 10993-20:2006 Biological evaluation of medical devices. Principles and methods for immunotoxicology testing of medical devices
BS EN ISO 14971:2009 Medical devices - Application of risk management to medical devices
BS EN ISO 14971:2012 Medical devices. Application of risk management to medical devices
BS EN ISO 10993-6:2016 Biological evaluation of medical devices. Tests for local effects after implantation
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 556-2:2024 Sterilization of medical devices. Requirements for medical devices to be designated "STERILE" - Requirements for aseptically processed medical devices
BS EN ISO 14971:2001 Medical devices - Application of risk management to medical devices
BS EN 556-2:2015 Sterilization of medical devices. Requirements for medical devices to be designated 'STERILE'. Requirements for aseptically processed medical devices
BS EN ISO 14971:2019 Medical devices. Application of risk management to medical devices
BS EN ISO 14971:2019+A11:2021 Medical devices - Application of risk management to medical devices
BS EN 62366-1:2015+A1:2020 Medical devices. Application of usability engineering to medical devices
BS EN ISO 10993-1:2003 Biological evaluation of medical devices - Evaluation and testing
BS PD ISO/TR 21582:2021 Pyrogenicity. Principles and methods for pyrogen testing of medical devices
PD ISO/TR 21582:2021 Pyrogenicity. Principles and methods for pyrogen testing of medical devices
BS EN 62366-1:2015 Medical devices. Application of usability engineering to medical devices
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 PD ISO/TR 80002-2:2017 Medical device software-Validation of software for medical device quality systems
BS ISO 17664-2:2021 Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices. Non-critical medical devices

Gosstandart of Russia

GOST ISO 10993-13-2016 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices
GOST R ISO 10993-13-2009 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices
GOST ISO 10993-23-2023 Medical devices. Biological evaluation of medical devices. Part 23. Irritant studies
GOST ISO 10993-6-2021 Medical devices. Biological evaluation of medical devices. Part 6. Tests for local effects after implantation
GOST R ISO 10993.6-1999 Medical devices. Biological evaluation of medical devices. Part 6. Tests for local effects after implantation
GOST R ISO 10993-6-2009 Medical devices. Biological evaluation of medical devices. Part 6. Tests for local effects after implantation
GOST ISO/TS 10993-20-2011 Medical devices. Biological evaluation of medical devices. Part 20. Principles and methods for immunotoxicology testing of medical devices
GOST R ISO 10993-1-2009 Medical devices. Biological evaluation of medical devices. Part 1. Evaluation and testing
GOST ISO 10993-10-2023 Medical devices. Biological evaluation of medical devices. Part 10. Sensitization tests
GOST ISO 14971-2011 Medical devices. Application of risk management to medical devices
GOST ISO 10993-1-2011 Medical devices. Biological evaluation of medical devices. Part 1. Evaluation and testing
GOST R ISO 10993-11-2009 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic toxicity
GOST ISO 10993-11-2021 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic toxicity
GOST R IEC 62366-2013 Medical devices. Application of usability engineering to medical devices
GOST R ISO 10993-11-1999 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic to xicity
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
GOST R ISO 10993-10-1999 Medical devices. Biological evaluation of medical devices. Part 10. Tests for irritation and sensitization
GOST R ISO 10993-18-2009 Medical devices. Biological evaluation of medical devices. Part 18. Chemical characterization of materials

German Institute for Standardization

DIN 13105 E:2008 Draft Document - Medical instruments- Autopsy knife
DIN 13198:1973-11 Medical instruments; ethmoid rongeur forceps Takahashi's
DIN EN ISO 14971:2001 Medical devices - Application of risk management to medical devices
DIN 13198:2010 Medical instruments - Ethmoid rongeur forceps type Takahashi
DIN EN ISO 14971:2020-07 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
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 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 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 556-2:2023-02 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: requirements for aseptically processed medical devices; German and English version prEN 556-2:2023 / Note: Date of issue 2023-01-06*Intended as r...
DIN EN 556-2:2015-11 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices; German version EN 556-2:2015 / Note: To be replaced by DIN EN 556-2 (2023-02).
DIN EN 13824:2005-02 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
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 ISO 14971 E:2018-08 Application of medical device risk management in medical devices (draft)
DIN EN ISO 14971:2022 Medical devices – applying risk management to medical devices
DIN EN 13824:2005 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
DIN EN 556-1:2024-09 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
DIN EN 556-2 E:2014 Draft Document - Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE'' - Part 2: Requirements for aseptically processed medical devices; German version prEN 556-2:2014
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
DIN EN 556-2:2025 Sterilization of Medical Devices - Requirements for Medical Devices to be Designated "STERILE" - Part 2: Requirements for Aseptically Processed Medical Devices
DIN EN ISO 14971:2007-07 Medical devices - Application of risk management to medical devices (ISO 14971:2007)
DIN EN 556-2:2004-03 Sterilization of medical devices - Requirements for medical devices to be designated STERILE - Part 2: Requirements for aseptically processed medical devices
DIN EN ISO 14971:2020 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
DIN EN ISO 14971:2022-04 Medical devices - Application of risk management to medical devices (ISO 14971:2019); German version EN ISO 14971:2019 + A11:2021

European Committee for Standardization (CEN)

EN ISO 14971:2007 Medical devices - Application of risk management to medical devices
EN ISO 14971:2009 Medical devices - Application of risk management to medical devices
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
EN ISO 14971:2000 Medical Devices - Application of Risk Management to Medical Devices (Incorporates Amendment A1: 2003)
EN ISO 14971:2019 Medical devices - Application of risk management to medical devices
CENELEC EN 62366-2008 Medical devices - Application of usability engineering to medical devices
EN 13824:2004 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
EN 556:1994 Sterilization of Medical Devices - Requirements for Medical Devices to Be Labelled `Sterile'

International Organization for Standardization (ISO)

ISO 14971:2019 Medical devices — Application of risk management to medical devices
ISO 14971:2000 Medical devices - Application of risk management to medical devices
ISO 14971:2019 Plus Redline Medical devices - Application of risk management to medical devices

Ente Nazionale Italiano di Unificazione

UNI EN ISO 14971:2008 Medical devices - Application of risk management to medical devices
UNI CEI EN ISO 14971:2012 Medical devices - Application of risk management to medical devices
UNI CEI EN ISO 14971:2002 Medical devices - Application of risk management to medical devices
UNI CEI EN ISO 14971:2004 Medical devices - Application of risk management to medical devices
UNI EN 556-1:2002 Sterilization of medical devices - Requirements for medical devices to be designated ?STERILE? - Requirements for terminally sterilized medical devices
UNI CEI EN ISO 14971:2020 Medical devices - Application of risk management to medical devices
EC 1-2004 UNI CEI EN ISO 14971:2004 Medical devices - Application of risk management to medical devices
UNI CEI EN ISO 14971:2022 Medical devices - Application of risk management to medical devices
UNI CEI EN ISO 14971:2009 Medical devices - Application of risk management to medical devices
UNI EN 556-1:2024 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
UNI EN ISO 17664-2:2024 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices
UNI EN 556:1996 Sterilization of medical devices. Requirements for medical devices to be labelled "Sterile".

Korean Agency for Technology and Standards (KATS)

KS P ISO 14971-2018 Medical devices — Application of risk management to medical devices
KS P ISO 14971:2021 Medical devices — Application of risk management to medical devices
KS P ISO 14971:2018 Medical devices — Application of risk management to medical devices
KS P ISO 14971-2021 Medical devices — Application of risk management to medical devices
KS P ISO 17664-2-2022 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 2: Non-critical medical devices

Japanese Industrial Standards Committee (JISC)

JIS T 14971:2003 Medical devices -- Application of risk management to medical devices
JIS T 14971:2012 Medical devices -- Application of risk management to medical devices
JIS T 14971:2020 Medical devices -- Application of risk management to medical devices

South African Bureau of Standard

SANS 14971:2008 Medical devices - Application of risk management to medical devices

Association Francaise de Normalisation

NF S99-211:2013 Medical devices - Application of risk management to medical devices
NF S99-211/A11*NF EN ISO 14971/A11:2021 Medical devices - Application of risk management to medical devices
NF EN ISO 14971:2019 Medical devices - Application of risk management to medical devices
NF EN ISO 14971/A11:2021 Medical devices - Application of risk management to medical devices
NF S98-116-2*NF ISO 17664-2:2021 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2 : non-critical medical devices
NF S98-107-2*NF EN 556-2:2024 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2 : requirements for aseptically processed medical devices
NF EN 556-1:2024 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
NF EN 556-1:2002 Sterilization of medical devices - Requirements for medical devices to obtain STERILE labeling - Part 1: Requirements for terminally sterilized medical devices
NF EN 556-2:2024 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2 : requirements for aseptically processed medical devices
NF S98-107-2*NF EN 556-2:2015 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE'' - Part 2 : requirements for aseptically processed medical devices
NF S98-107-1*NF EN 556-1:2024 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices

Thai Industrial Standards Institute (TISI)

TIS 14971-2013 Medical devices.application of risk management to medical devices

International Electrotechnical Commission (IEC)

IEC 62366:2014 Medical devices - Application of usability engineering to medical devices
IEC 62366:2007 Medical devices - Application of usability engineering to medical devices
IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices

Swedish Institute for Standards

SS-EN 13532:2003 General requirements for in vitro diagnostic medical devices for self-testing
SS-EN ISO 14971:2007 Medical devices - Application of risk management to medical devices (ISO 14971:2007)
SS-EN 13824:2005 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
SS-EN 556-2:2024 Sterilization of medical devices — Requirements for medical devices to be designated ''STERILE" — Part 2: requirements for aseptically processed medical devices
SS-EN 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices

Danish Standards Foundation

DANSK DS/ISO/TR 21582:2021 Pyrogenicity – Principles and methods for pyrogen testing of medical devices
DS/ISO/TR 21582:2021 Pyrogenicity – Principles and methods for pyrogen testing of medical devices
DANSK DS/EN ISO 14971:2012 Medical devices – Application of risk management to medical devices
DANSK DS/ISO 14971:2020 Medical devices – Application of risk management to medical devices
DS/EN ISO 14971:2013 Medical devices - Application of risk management to medical devices
DANSK DS/EN 62366:2008 Medical devices - Application of usability engineering to medical devices
DANSK DS/EN 62366/A1:2008 Medical devices - Application of usability engineering to medical devices
DS/EN 62366:2008 Medical devices - Application of usability engineering to 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
DANSK DS/ISO 17664-2:2021 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 2: Non-critical 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
DANSK DS/EN 556-2:2015 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed 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
DANSK DS/ISO 17664-1:2021 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 1: Critical and semi-critical medical devices
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 556-2:2004 Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 2: Requirements for aseptically processed medical devices

Standard Association of Australia （SAA）

AS ISO 14971:2020 Medical devices — Application of risk management to medical devices

Canadian Standards Association (CSA)

CAN/CSA-ISO 14971:2007(R2012) Medical Devices - Application of Risk Management to Medical Devices
CAN/CSA-ISO 14971:2007(C2012) Medical devices - Application of risk management to medical devices
CAN/CSA-ISO 14971:2001(R2006) Medical Devices - Application of Risk Management to Medical Devices
CAN/CSA-ISO 14971:2001(C2006) Medical devices - Application of risk management to medical devices
CAN/CSA-ISO 17664-2-2023 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 2: Non-critical medical devices
CSA ISO 17664-2:2023 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 2: Non-critical medical devices
CSA IEC 62366-1-2015(R2021) Medical devices — Part 1: Application of usability engineering to medical devices
CSA ISO 14971-07-CAN/CSA:2007 Medical Devices - Application of Risk Management to Medical Devices second edition

Spanish Association for Standardization (UNE)

UNE-EN ISO 14971:2020/A11:2022 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
UNE-EN ISO 14971:2020 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
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 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 13824:2005 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
UNE-EN 556-2:2016 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices
UNE-EN 556-2:2004 Sterilization of medical devices - Requirements for medical devices to be designated STERILE - Part 2: Requirements for aseptically processed medical devices
UNE-EN ISO 14971:2007 Medical devices - Application of risk management to medical devices (ISO 14971:2007)

GCC Standardization Organization

BH GSO ISO 14971:2024 Medical devices — Application of risk management to medical devices
OS GSO ISO 14971:2024 Medical devices — Application of risk management to medical devices
GSO ISO 14971:2015 Medical devices -- Application of risk management to medical devices
GSO ISO 17664-2:2023 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 2: Non-critical medical devices
OS GSO ISO 14708-3:2024 Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators

Comitato Elettrotecnico Italiano

CEI UNI EN ISO 14971:2020 Medical devices - Application of risk management to medical devices
CEI EN 62366:2008 Medical devices - Application of usability engineering to medical devices
CEI EN 62366/A1:2008 Medical devices - Application of usability engineering to medical devices

Kingdom of Bahrain Testing and Metrology Directorate

BH GSO ISO 14971:2017 Medical devices -- Application of risk management to medical devices
BH GSO ISO 17664-2:2023 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 2: Non-critical medical devices

Association for the Advancement of Medical Instrumentation

AAMI/ISO 14971:2019 Medical devices - Application of risk management to medical devices
AAMI/ISO 14971:2007(R2016) Medical Devices - Application of Risk Management to Medical Devices
AAMI/IEC 62366:2007 Medical devices - Application of usability engineering to medical devices
AAMI/IEC 62366:2007(R2013) Medical devices - Application of usability engineering to medical devices
AAMI EQ93:2019(R2025) Medical equipment management - Vocabulary used in medical equipment programs
AAMI/ISO 17664-2:2022 Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices—Part 2: Non-critical medical devices
AAMI TIR 12:2020(R2023) Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers
AAMI/ISO 17664-1:2022 Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices—Part 1: Critical and semi-critical medical devices

The Directorate General of Specifications and Metrology (DGSM)

OS GSO ISO 14971:2015 Medical devices -- Application of risk management to medical devices
OS GSO IEC 62366:2014 Medical devices - Application of usability engineering to medical devices

American National Standards Institute （ANSI)

ANSI/AAMI/ISO 14971:2019 Medical devices— Application of risk management to medical devices
ANSI/AAMI/ISO 17664-2:2022 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices

European Committee for Electrotechnical Standardization（CENELEC）

EN 62366:2008 Medical devices - Application of usability engineering to medical devices

Association for Electrical, Electronic & Information Technologies (VDE)

DIN EN IEC 60601-2-68:2025-12*VDE 0750-2-68:2025-12 Medical electrical equipment
DIN EN IEC 60601-2-21:2025-07*VDE 0750-2-21 Berichtigung 1:2025-07 Medical electrical equipment
DIN EN 60601-1/A13:2025-03*VDE 0750-1/A13:2025-03 Medical electrical equipment
DIN EN 60601-2-3:2025-07*VDE 0750-2-3:2025-07 Medical electrical equipment
DIN IEC/TS 60601-4-2:2025-06*VDE V 0750-4-2:2025-06 Medical electrical equipment
DIN EN IEC 60601-2-54:2025-05*VDE 0750-2-54:2025-05 Medical electrical equipment
DIN EN IEC 60601-2-16:2026-02*VDE 0750-2-16:2026-02 Medical electrical equipment

Lithuanian Standards Office

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 556-2-2004 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices
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

Standards Norway

NS-EN 556-2:2015 Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 2: Requirements for aseptically processed medical devices
NS-EN 13824:2004 Sterilization of medical devices — Aseptic processing of liquid medical devices — Requirements
NS-EN 556-2:2003 Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 2: Requirements for aseptically processed 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
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 ISO 14971:2019 Medical devices — Application of risk management to medical devices (ISO 14971:2019)
NS-EN ISO 14971:2007 Medical devices - Application of risk management to medical devices (ISO 14971:2007)
NS-EN 556:1994 Sterilization of medical devices — Requirements for medical devices to be labelled "Sterile"

Asociación Española de Normalización (AENOR)

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

Canadian General Standards Board （CGSB)

CAN/CGSB-2.161-M91-1991 Assessment of Efficacy of Antimicrobial Agents for Use on Environmental Surfaces and Medical Devices