Sales of Class II Medical Devices

Sales of Class II Medical Devices, Total:200 items.

The international standard classification for "Sales of Class II Medical Devices" includes: Medical equipment in general , Medical equipment .

The Chinese standard classification for "Sales of Class II Medical Devices" includes: Medical apparatus and devices in general , Public medical equipment .

Shanghai Provincial Standard of the People's Republic of China

DB31/T 1378-2022 Service Specifications for Class II Medical Device Registration

Group Standards of the People's Republic of China

T/SHSPTA 003-2024 Specification for medical device advertisement compliance management by retail enterprises
T/SHSPTA 007-2024 Compliance Management Norms for Advertising of Medical Devices in Retail Enterprises

Professional Standard - Medicine

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 0316-2016 Medical devices-Application of risk management to medical devices
YY/T 0802-2020 Processing of medical devices—Information to be provided by the medical device manufacturer
YY/T 1474-2016 Medical devices－Application of risk management to medical devices
YY/T 0316-2003 Medical devices -- Application of risk management to medical devices
YY/T 0316-2008 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

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

Canadian Standards Association (CSA)

CSA ISO 14971-07-CAN/CSA:2007 Medical Devices - Application of Risk Management to Medical Devices second edition
CAN/CSA-ISO 14971:2007 Medical Devices - Application of Risk Management to Medical Devices (Second Edition)
CAN/CSA-ISO 14971-2007(R2017) Medical Devices - Application of Risk Management to Medical Devices (Adopted ISO 14971:2007, second edition, 2007-03-01)
CAN/CSA-ISO 14971:2007(C2012) Medical devices - Application of risk management to medical devices
CAN/CSA-ISO 14971:2007(R2012) 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

Association Francaise de Normalisation

NF S99-015*NF EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates.
NF EN 15986:2011 Symbol for use in the labeling of medical devices - Requirements for the labeling of medical devices containing phthalates
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 S98-107-2*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 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
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 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 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 S98-107-2:2004 "Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 2 : requirements for aseptically processed medical devices".
NF EN 556-2:2015 Sterilization of medical devices - Requirements for medical devices to obtain the "STERILE" label - Part 2: Requirements for medical devices subject to aseptic processing

Swedish Institute for Standards

SS-EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
SS-EN ISO 14971:2007 Medical devices - Application of risk management to medical devices (ISO 14971:2007)
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 13824:2005 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
SS-EN 556-1:2024 Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 1: Requirements for terminally sterilized 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
SS-EN 556-2:2015 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices

Ente Nazionale Italiano di Unificazione

UNI CEI EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
UNI EN ISO 14971:2008 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 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 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 556:1996 Sterilization of medical devices. Requirements for medical devices to be labelled "Sterile".
UNI EN 556-2:2025 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed 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

Spanish Association for Standardization (UNE)

UNE-EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
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 556-2:2004 Sterilization of medical devices - Requirements for medical devices to be designated STERILE - Part 2: Requirements for aseptically processed 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 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 13824:2005 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements

German Institute for Standardization

DIN 58860:2010-02 Medical instruments - Osteotomes type Lexer
DIN EN 15986:2011-05 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates; German version EN 15986:2011, with CD-ROM
DIN EN 15986 E:2009-08 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
DIN 58257:1983-02 Medical instruments; needle holder type Crile
DIN 58259:2010-02 Medical instruments - Needle holder type Masson
DIN EN 15986 E:2009 Draft Document - Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates; German version prEN 15986:2009
DIN 13452:2006-12 Medical instruments - Scissors type Kilner
DIN 58257:2010-02 Medical instruments - Needle holder type Crile
DIN 58262:2010-02 Medical instruments - Mouth gag type Jennings
DIN 58785:2010-02 Medical instruments - Ear specula type Hartmann
DIN 13452:2017-11 Medical instruments - Scissors type Kilner
DIN 58858:2008-01 Medical Instruments - Director Type KÃ¶nig
DIN EN ISO 14971:2001 Medical devices - Application of risk management to medical devices
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 58259:1976-03 Medical instruments; needle holder type Masson
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 96111:2010-12 Medical instruments - Plaster knife type Körte
DIN EN ISO 14971:2020-07 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
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 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 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 96035:2009-12 Medical instruments - Haemostatic forceps type Semb
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 556-2:2004 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices; German version EN 556-2:2003
DIN EN ISO 14971 E:2018-08 Application of medical device risk management in medical devices (draft)
DIN 58788:1982-09 Medical instruments; nasal specula type Hartmann-Halle
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 58263 E:2008 Draft Document - Medical instruments - Mouth gag type Heister
DIN 58286:2010-02 Medical instruments - Retractor type Kocher
DIN EN 13824:2005 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
DIN EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates; German version EN 15986:2011, with CD-ROM
DIN 58860 E:2008-09 Draft Document - Medical instruments - Osteotomes type Lexer

European Committee for Standardization (CEN)

EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
EN ISO 14971:2009 Medical devices - Application of risk management to medical devices
EN ISO 14971:2007 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 14971:2019 Medical devices - Application of risk management to medical devices
EN ISO 14971:2000 Medical Devices - Application of Risk Management to Medical Devices (Incorporates Amendment A1: 2003)
CENELEC EN 62366-2008 Medical devices - Application of usability engineering to medical devices
EN 556:1994 Sterilization of Medical Devices - Requirements for Medical Devices to Be Labelled `Sterile'
EN 556-2:2003 Sterilization of medical devices Requirements for medical devices to be designated STERILE Part 2: Requirements for aseptically processed medical devices
EN 556-2:2015 "Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 2: Requirements for aseptically processed medical devices"
EN 13824:2004 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements

Danish Standards Foundation

DS/EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
DANSK DS/EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
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 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/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 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
DS/EN 556:1995 Sterilization of medical devices - Requirements for medical devices to be labelled "Sterile"
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 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
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

Lithuanian Standards Office

LST EN 15986-2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
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

Korean Agency for Technology and Standards (KATS)

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 14971:2018 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

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
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

Standards Norway

NS-EN 15986:2011 Symbol for use in the labelling of medical devices — Requirements for labelling of medical devices containing phthalates
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 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 13824:2004 Sterilization of medical devices — Aseptic processing of liquid medical devices — Requirements
NS-EN ISO 14971:2019 Medical devices — Application of risk management to medical devices (ISO 14971:2019)

British Standards Institution (BSI)

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 556-1:2024 Sterilization of medical devices. Requirements for medical devices to be designated "STERILE" - Requirements for terminally sterilized medical devices
BS EN 556-2:2015 Sterilization of medical devices. Requirements for medical devices to be designated 'STERILE'. Requirements for aseptically processed 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
09/30205582 DC BS EN 15986. Symbol for use in the labelling of medical devices. Requirements for labelling of medical devices containing phthalates
19/30378069 DC BS ISO 17664-2. 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
BS EN ISO 14971:2001 Medical devices - Application of risk management to 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 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

Comitato Elettrotecnico Italiano

CEI UNI EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
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

South African Bureau of Standard

SANS 14971:2008 Medical devices - Application of risk management to medical devices
SANS 1593:1994 Disinfectants based on glutaraldehyde for use on medical instruments

US Federal Contractor Registration (USFCR)

FCR 21 CFR PART 860-2015 MEDICAL DEVICE CLASSIFICATION PROCEDURES
FCR 21 CFR PART 860-2013 MEDICAL DEVICE CLASSIFICATION PROCEDURES

Thai Industrial Standards Institute (TISI)

TIS 14971-2013 Medical devices.application of risk management to 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/ISO 17664:2017 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of 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

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

Standard Association of Australia （SAA）

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

Code of Federal Regulations (CFR)

CFR 31-560.533-2014 Money and Finance: Treasury. Part560:Iranian transactions and sanctions regulations. Section560.533:Brokering commercial sales of agricultural commodities, medicine, and medical devices.

National Standardisation Body (ASRO)

STAS 10719/1-1984 MEDICAL INSTRUMENTS Clasification and terminology

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

Gosstandart of Russia

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 ISO 10993-13-2011 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices

European Committee for Electrotechnical Standardization（CENELEC）

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

Asociación Española de Normalización (AENOR)

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

European Union/Commission

MEDDEV 2.4/1 PART 2-2001 Guidelines for the Classification of Medical Devices Rev 8

Finnish Standards Institute

SFS-EN 556-2:2024 Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Part 2: Requirements for aseptically processed medical devices

Bureau of Indian Standards

IS/ISO 15223-1-2016 Medical Devices — Symbols to be Used with Medical Device Labels, Labelling and Information to be Supplied Part — General Requirements ( Second Revision )
IS/ISO 17664-2017 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices

GCC Standardization Organization

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

Others: R&D of Class II medical devices,Maintenance and maintenance of Class II medical devices,Research on Class II Medical Devices,Sales of Class II Medical Devices,Sales of Class II Medical Devices,Sales of Class II Medical Devices