Biomedical Devices

Biomedical Devices, Total:68 items.

The international standard classification for "Biomedical Devices" includes: Medical equipment in general , Sterilization and disinfection in general , Dental materials .

The Chinese standard classification for "Biomedical Devices" includes: Medical apparatus and devices in general , Public medical equipment , Stomatologic device, equipment and material .

Group Standards of the People's Republic of China

T/CAMDI 033-2020 Guide for biological evaluation of packaging materials for medical devices
T/CAMDI 039-2020 Special requirements for the production quality system of bioprinted medical devices

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

GB/T 16886.1-2001 Biological evaluation of medical devices--Part 1:Evaluation and testing
GB/T 16886.2-2011 Biological evaluation of medical devices—Part 2:Animal welfare requirements
GB/T 16886.6-2015 Biological evaluation of medical devices―Part 6:Tests for local effects after implantation

国家药监局

YY/T 1737-2020 Analytical method for bioburden control level of medical device

Professional Standard - Medicine

YY/T 0127.3-2014 Biological evaluation of medical devices used in dentistry―Part 3:Endodontic usage test
YY/T 0268-2008 Dentistry - Biological evaluation of medical devices used in dentistry Part1: Evaluation and test
YY/T 0127.11-2014 Biological evaluation of medical devices used in dentistry―Part 11:Pulp capping test

国家市场监督管理总局、中国国家标准化管理委员会

GB/T 16886.6-2022 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation

SCC

BS EN ISO 22442-1:2007 Medical devices utilizing animal tissues and their derivatives-Application of risk management
BS EN ISO 22442-2:2007 Medical devices utilizing animal tissues and their derivatives-Controls on sourcing, collection and handling
AAMI/ISO 22442-1:2016 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
DANSK DS/ISO 22442-1:2020 Medical devices utilizing animal tissues and their derivatives – Part 1: Application of risk management
DANSK DS/ISO 22442-2:2020 Medical devices utilizing animal tissues and their derivatives – Part 2: Controls on sourcing, collection and handling
AAMI/ISO 22442-2:2016 Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling
NS-EN ISO 22442-1:2020 Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management (ISO 22442-1:2020)
DANSK DS/EN ISO 22442-1:2020 Medical devices utilizing animal tissues and their derivatives – Part 1: Application of risk management (ISO 22442-1:2020)
NS-EN ISO 22442-1:2015 Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management (ISO 22442-1:2015)
05/30106190 DC EN ISO 22442-1. Medical devices utilizing animal tissues and their derivatives. Part 1. Application of risk management
NS-EN ISO 22442-1:2007 Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management (ISO 22442-1:2007)
05/30106194 DC EN ISO 22442-2. Medical devices utilizing animal tissues and their derivatives. Part 2. Controls on sourcing, collection and handling
NS-EN ISO 22442-2:2015 Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2015)
DANSK DS/EN ISO 22442-2:2020 Medical devices utilizing animal tissues and their derivatives – Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020)
NS-EN ISO 22442-2:2020 Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020)
DIN EN ISO 22442-1 E:2018 Draft Document - Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO/DIS 22442-1:2018); German and English version prEN ISO 22442-1:2018
NS-EN ISO 22442-2:2007 Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2007)
DIN EN ISO 22442-2 E:2018 Draft Document - Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO/DIS 22442-2:2018); German and English version prEN ISO 22442-2:2018

GOSTR

GOST R ISO 22442-1-2011 Medical devices utilizing animal tissues and their derivatives. Part 1. Application of risk management
GOST R ISO 22442-2-2011 Medical devices utilizing animal tissues and their derivatives. Part 2. Controls on sourcing, collection and handling

British Standards Institution (BSI)

BS EN ISO 10993-17:2023 Biological evaluation of medical devices - Toxicological risk assessment of medical device constituents
DD ISO/TS 10993-20:2006 Biological evaluation of medical devices. Principles and methods for immunotoxicology testing of medical devices
BS EN ISO 22442-3:2007 Medical devices utilizing animal tissues and their derivatives - Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents

GSO

GSO ISO 22442-1:2016 Medical devices utilizing animal tissues and their derivatives -- Part 1: Application of risk manag ement
BH GSO ISO 22442-1:2017 Medical devices utilizing animal tissues and their derivatives -- Part 1: Application of risk manag ement
GSO ISO 22442-1:2024 Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management
OS GSO ISO 22442-1:2016 Medical devices utilizing animal tissues and their derivatives -- Part 1: Application of risk manag ement
OS GSO ISO 22442-2:2016 Medical devices utilizing animal tissues and their derivatives -- Part 2: Controls on sourcing, collection and handling
GSO ISO 22442-2:2016 Medical devices utilizing animal tissues and their derivatives -- Part 2: Controls on sourcing, collection and handling

IT-UNI

UNI EN ISO 22442-1:2021 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
UNI EN ISO 22442-2:2021 Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling

Association Francaise de Normalisation

NF EN ISO 22442-1:2020 Medical devices using animal tissues and their derivatives - Part 1: application of risk management
NF EN ISO 22442-2:2020 Medical devices using animal tissues and their derivatives - Part 2: controls of origin, collection and processing

KR-KS

KS P ISO 22442-1-2022 Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management
KS P ISO 22442-2-2022 Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling

American National Standards Institute （ANSI)

ANSI/AAMI/ISO 22442-1:2016 Medical devices utilizing animal tissues and their derivatives—Part 1: Application of risk management
ANSI/AAMI/ISO 22442-2:2016 Medical devices utilizing animal tissues and their derivatives—Part 2: Controls on sourcing, collection and handling

German Institute for Standardization

DIN EN ISO 22442-1:2021-08 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020); German version EN ISO 22442-1:2020 / Note: Applies in conjunction with DIN EN ISO 14971 (2020-07).
DIN EN ISO 22442-2:2021-04 Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020); German version EN ISO 22442-2:2020
DIN EN ISO 10993-18:2009 Biological assessment of medical devices

Danish Standards Foundation

DS/ISO 22442-1:2020 Medical devices utilizing animal tissues and their derivatives – Part 1: Application of risk management
DS/ISO 22442-2:2020 Medical devices utilizing animal tissues and their derivatives – Part 2: Controls on sourcing, collection and handling
DS/EN ISO 22442-1:2020 Medical devices utilizing animal tissues and their derivatives – Part 1: Application of risk management (ISO 22442-1:2020)
DS/EN ISO 22442-2:2020 Medical devices utilizing animal tissues and their derivatives – Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020)

Spanish Association for Standardization (UNE)

UNE-EN ISO 22442-1:2022 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020)
UNE-EN ISO 22442-1:2008 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2007)
UNE-EN ISO 22442-2:2022 Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020)
UNE-EN ISO 22442-2:2008 Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2007)

Lithuanian Standards Office

LST EN ISO 22442-1:2021 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020)
LST EN ISO 22442-2:2021 Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020)

AT-ON

OENORM EN ISO 22442-1:2021 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020)
OENORM EN ISO 22442-2:2021 Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020)

PL-PKN

PN-EN ISO 22442-1-2021-04 E Medical devices utilizing animal tissues and their derivatives -- Part 1: Application of risk management (ISO 22442-1:2020)
PN-EN ISO 22442-2-2021-04 E Medical devices utilizing animal tissues and their derivatives -- Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020)

CH-SNV

SN EN ISO 22442-1:2021 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020)
SN EN ISO 22442-2:2021 Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020)

IX-EU/EC

2000/70/EC-2000 Directive of the European Parliment and of the Council Amending Council Directive 93/42/EEC as Regards Medical Devices Incorporating Stable Derivates of Human Blood or Human Plasma

International Organization for Standardization (ISO)

ISO/CD 10993-1.2:2023 Biological evaluation of medical devices