Technical Requirements for Class II Medical Devices

Technical Requirements for Class II Medical Devices, Total:101 items.

The international standard classification for "Technical Requirements for Class II Medical Devices" includes: Surgical instruments and materials , Implants for surgery, prosthetics and orthotics .

The Chinese standard classification for "Technical Requirements for Class II Medical Devices" includes: Medical apparatus and devices in general , Orthopedic devices .

Professional Standard - Medicine

YY/T 1570-2017 Tissue engineering medical device products—Terminology,classification and nomination of skin substitute
YY/T 0048-1991 Basic requirements for working drawings of medical device products
YY/T 1914-2023 Medical devices for human assisted reproductive technology―General requirements of apparatus products
YY 91055-1999 Paint coating for medical devices. Classification and speciation
YY/T 1445-2016 Tissue engineering medical device products--Terminology

Group Standards of the People's Republic of China

T/SAMD 0005-2023 Technical Guidelines for Domestic Class I Medical Device Filing

Henan Provincial Standard of the People's Republic of China

DB41/T 2656-2024 Product registration self-inspection system requirements for medical device manufacturers

Guangdong Provincial Standard of the People's Republic of China

DB4420/T 45-2024 Specifications for registration management of Class I medical device products

Professional Standard - Post and Telecommunication

YD/T 6284-2024 Technical requirements for intelligent medical device cybersecurity capabilities

Shanghai Provincial Standard of the People's Republic of China

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

Swedish Institute for Standards

SIS-ISO/TS 22421:2021 Sterilization of health care products - Common requirements for sterilizers forterminal sterilization of medical devices in health care facilities (ISO/TS 22421:2021)
SS-EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
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 556-2:2015 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

Gosstandart of Russia

GOST R 55954-2018 Medical equipment. Lung ventilators. Technical requirements for governmental purchases
GOST R 57504-2017 Medical devices. Syringe pumps. Technical requirements for governmental purchases
GOST R 50444-2020 Medical instruments, apparatus and equipment. General technical requirements
GOST R 71579-2024 Medical electrical equipment. Phototherapy devices. Technical condition control methods
GOST R 57765-2021 Prosthetic-orthopedic products. General technical requirements
GOST R 57765-2017 Medical equipment. Products prosthetic-orthopedic. General technical requirements
GOST R 55771-2024 Medical electrical equipment. X-ray computer tomograph. Technica requirements for governmental purchases
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 57505-2017 Medical devices. Cochlear implant system. Technical requirements for governmental purchases
GOST R 57500-2017 Medical devices. Implantable infusion pumps. Technical requirements for governmental purchases

Bureau of Indian Standards

IS 18287-2023 Sterilization Of Health Care Products Common Requirements For Sterilizers For Terminal Sterilization Of Medical Devices In Health Care Facilities

Spanish Association for Standardization (UNE)

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.
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 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
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 556-2:2016 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices
AENOR 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
AENOR UNE-EN 15986:2011 Symbol for use in the labeling of medical devices - Requirements for labeling of medical devices containing phthalates
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 13824:2005 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements

National Standardisation Body (ASRO)

STAS 12902-1990 Human being medical instruments. Dental extracting forceps. General technical requirements for quality
STAS 12916-1991 Human use medical instruments. Retractors. General technical requirements for quality
STAS 12670-1988 Medical instruments SURGICAL SCISSORS General technical requirements for quality
STAS 10719/1-1984 MEDICAL INSTRUMENTS Clasification and terminology

British Standards Institution (BSI)

BS EN ISO 17665-1:2006 Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for 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 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 556-1:2001(2006) Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 1 : Requirements for terminally sterilized 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

Danish Standards Foundation

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

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 556-1:2002 Sterilization of medical devices - Requirements for medical devices to be designated ?STERILE? - Requirements for terminally sterilized 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 17664:2018 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of 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.
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
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 Sterilization of medical devices - Requirements for medical devices to obtain STERILE labeling - Part 1: Requirements for terminally sterilized medical devices
NF EN 15986:2011 Symbol for use in the labeling of medical devices - Requirements for the labeling of medical devices containing phthalates
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 556-2:2024 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

Polski Komitet Normalizacyjny (PKN)

PN Z54094-1972 Medical and surgical instruments Forceps Technical requirements and tes?s
PN Z58022-1973 Medical instruments ynaecological curettes echnical requirements and tests

Association for the Advancement of Medical Instrumentation

AAMI ST67:2011(R2017) Sterilization of Health Care Products--Requirements for Products Labeled 'STERILE'
AAMI ST98:2022 Cleaning validation of health care products - Requirements for development and validation of a cleaning process for medical devices
AAMI ST98-2022

German Institute for Standardization

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 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 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 556-1 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 556-1:2024 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 556-2:2004-03 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 EN 13824:2005 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
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

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 15986-2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
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 556-2-2004 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices

Standards Norway

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 15986:2011 Symbol for use in the labelling of medical devices — Requirements for labelling of medical devices containing phthalates
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 556-2:2015 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

US Federal Contractor Registration (USFCR)

FCR 21 CFR PART 821-2015 MEDICAL DEVICE TRACKING REQUIREMENTS

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 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'

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

Others: Technical requirements for non-medical device products,Technical requirements for medical device products,Technical requirements for medical device products,Technical Requirements for Class II Medical Devices,Technical Requirements for Class II Medical Devices,Technical requirements for Class III medical device products,Technical requirements for medical device inspection products