Animal Tissues for Medical Devices

Animal Tissues for Medical Devices, Total:199 items.

The international standard classification for "Animal Tissues for Medical Devices" includes: Implants for surgery, prosthetics and orthotics , Medical equipment , Medical equipment in general .

The Chinese standard classification for "Animal Tissues for Medical Devices" includes: Orthopedic devices , Extracorporeal circulation, artificial organ and prosthesis device , Medical apparatus and devices in general .

未注明发布机构

DIN 58239-1:2016-03 Medical instruments - Tissue forceps - Part 1: Straight
DIN 58239-2 E:2016-07 Medical instruments - Tissue forceps - Part 2: Curved
DIN EN ISO 14971:2001 Medical devices - Application of risk management to medical devices
DIN 58239-2 E:2022-08 Medical instruments - Tissue forceps - Part 2: Curved
ANSI/AAMI/ISO 22442-1:2016 Medical devices utilizing animal tissues and their derivatives—Part 1: Application of risk management
DIN 13171 E:2017-06 Medical instruments - Tissue forceps type Adson-Brown
DIN 58239-1 E:2015-09 Medical instruments - Tissue forceps - Part 1: Straight
ANSI/AAMI/ISO 22442-2:2016 Medical devices utilizing animal tissues and their derivatives—Part 2: Controls on sourcing, collection and handling
DIN 58239-1 E:2022-08 Medical instruments - Tissue forceps - Part 1: Straight
ANSI/AAMI/ISO 14971:2019 Medical devices— Application of risk management to medical devices
DIN 13193 E:2016-07 Medical instruments - Rongeurs type Luer
DIN 13193 E:2022-08 Medical instruments - Rongeurs type Luer
DIN EN ISO 14971:2022 Medical devices – applying risk management to medical devices
DIN EN ISO 10993-18:2009 Biological assessment of medical devices
ANSI/AAMI/ISO 14160:2011(2016) Sterilization of health care products — Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives — Requirements for characterization, development, validation and routine control of a sterilization pr

国家食品药品监督管理局

YY/T 1616-2018 Tissue engineering medical device products—Standard guide for characterization and testing of biomaterial scaffolds
YY/T 1561-2017 Tissue engineering medical device products-Remnant a-Gal antigen determination in scaffold materials utilizing animal tissues and their derivatives
YY/T 1575-2017 Tissue engineering medical device products—Standard guide for in vivo assessment of implantable devices intended to repair or regenerate bone defect
YY/T 1435-2016 Tissue engineering medical device products―Standard guide for characterization of hydrogels
YY/T 1445-2016 Tissue engineering medical device products--Terminology
YY/T 1571-2017 Tissue engineering medical device products—Sodium hyaluronate
YY/T 1562-2017 Tissue engineering medical device products-Biomaterial scaffolds-Guide for cell viability evaluation
YY/T 1474-2016 Medical devices－Application of risk management to medical devices
YY/T 1570-2017 Tissue engineering medical device products—Terminology,classification and nomination of skin substitute
YY/T 1576-2017 Tissue engineering medical device products—Standard practice for implantation assessment of absorbable/resorbable biomaterials
YY/T 1577-2017 Tissue engineering medical device products—Standard guide for microstructure of polymeric scafforlds

Professional Standard - Medicine

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 1815-2022 Biological evaluation of medical devices-Application for the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
YY/T 1912-2023 Biological evaluation and testing of medical devices for soft tissue regeneration
YY/Y 1576-2017 Implantation Test of Absorbable Biomaterials for Tissue Engineering Medical Devices
YY/T 0316-2016 Medical devices-Application of risk management to medical devices

国家药监局

YY/T 0771.1-2020 Medical devices utilizing animal tissues and their derivatives—Part 1:Application of risk management
YY/T 1654-2019 Tissue engineering medical device products—Alginate
YY/T 1699-2020 Tissue engineering medical device products—Chitosan
YY/T 1716-2020 Tissue engineering medical device products—Characterization of ceramic and mineral based scaffolds

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

GB/T 42062-2022 Medical devices—Application of risk management to medical devices

Professional Standard - Agriculture

GB/T 44353.1-2024 Medical devices utilizing animal tissues and their derivatives—Part 1:Application of risk management

Group Standards of the People's Republic of China

T/SZZX 015-2023 Mechanically actuated micro-plunger pumps for medical devices
T/SAMD 0003-2023 Mechanically actuated micro-plunger pumps for medical devices

IX-EU/EC

NO 722/2012-2012 COMMISSION REGULATION concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal o
MEDDEV 2.11/1-2005 GUIDELINES ON MEDICAL DEVICES APPLICATION OF COUNCIL DIRECTIVE 93/42/EEC TAKING INTO ACCOUNT THE COMMISSION DIRECTIVE 2003/32/EC FOR MEDICAL DEVICES UTILISING TISSUES OR DERIVATIVES ORIGINATING FROM ANIMALS FOR WHICH A TSE RISK IS SUSPECTED Rev 1

German Institute for Standardization

DIN 58239-1:1983 Medical instruments; tissue forceps
DIN 58239-2:1983 Medical instruments; tissue forceps, curved
DIN 13171:2017-11 Medical instruments - Tissue forceps type Adson-Brown
DIN 13171:2006 Medical instruments - Tissue forceps type Adson-Brown
DIN 13171:2017 Medical instruments - Tissue forceps type Adson-Brown
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 58239-1:2023-03 Medical instruments - Tissue forceps - Part 1: Straight
DIN 58239-2:2023-03 Medical instruments - Tissue forceps - Part 2: Curved
DIN 58239-1:2009 Medical instruments - Tissue forceps - Part 1: Straight
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 58239-2:2016 Medical instruments - Tissue forceps - Part 2: Curved
DIN 58239-2:2010 Medical instruments - Tissue forceps - Part 2: Curved
DIN 13193:2023-03 Medical instruments - Rongeurs type Luer
DIN 96145:2011 Medical instruments - Tissue forceps type Gillies

SCC

BS EN ISO 22442-1:2007 Medical devices utilizing animal tissues and their derivatives-Application of risk management
DIN 13171 E:2017 Draft Document - Medical instruments - Tissue forceps type Adson-Brown
DIN 96145 E:2011 Draft Document - Medical instruments - Tissue forceps type Gillies
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
BS EN ISO 22442-2:2007 Medical devices utilizing animal tissues and their derivatives-Controls on sourcing, collection and handling
NS-EN 12442-1:2000 Animal tissues and their derivatives utilized in the manufacture of medical devices — Part 1: Analysis and management of risk
BS 5736-2:1981 Evaluation of medical devices for biological hazards-Method of testing by tissue implantation
DIN 58239-1:2016 Medical instruments - Tissue forceps - Part 1: Straight
BS 5736-2:1990 Evaluation of medical devices for biological hazards-Methods of testing by tissue implantation
UNE-EN 12442-1:2001 Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 1: Analysis and management of risk.
NS-EN ISO 22442-1:2007 Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management (ISO 22442-1:2007)
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)
UNE-EN ISO 22442-1:2008 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2007)
NS-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
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
DIN 58239-2 E:2016 Draft Document - Medical instruments - Tissue forceps - Part 2: Curved
UNE-EN 12442-2:2001 Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 2: Controls on sourcing, collection and handling
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 12442-2:2000 Animal tissues and their derivatives utilized in the manufacture of medical devices — Part 2: Controls on sourcing, collection and handling
05/30106194 DC EN ISO 22442-2. Medical devices utilizing animal tissues and their derivatives. Part 2. Controls on sourcing, collection and handling
DIN 58239-1 E:2015 Draft Document - Medical instruments - Tissue forceps - Part 1: Straight
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 22442-2:2015 Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2015)
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)
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)
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)
BS EN ISO 10993-2:1998 Biological evaluation of medical devices-Animal welfare requirements
AAMI/IEC 62366:2007 Medical devices - Application of usability engineering to medical devices
CEI EN 62366:2008 Medical devices - Application of usability engineering to medical devices
AENOR UNE-EN 62366:2009 Medical devices - Application of usability engineering to medical devices
DANSK DS/EN 62366:2008 Medical devices - Application of usability engineering to medical devices
AENOR UNE-EN 62366/A1:2009 Medical devices - Application of usability engineering to medical devices
CEI EN 62366/A1:2008 Medical devices - Application of usability engineering to medical devices
DANSK DS/EN 62366/A1:2008 Medical devices - Application of usability engineering to medical devices
CAN/CSA-ISO 14971:2007(C2012) Medical devices - Application of risk management to medical devices
CEI UNI EN ISO 14971:2020 Medical devices - Application of risk management to medical devices
AAMI/ISO 14971:2019 Medical devices - Application of risk management to medical devices
CAN/CSA-ISO 14971:2007(R2012) Medical Devices - Application of Risk Management to 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
CAN/CSA-ISO 14971:2001(R2006) Medical Devices - Application of Risk Management to Medical Devices
ISO 14971:2019 Plus Redline Medical devices - Application of risk management to medical devices
BS EN ISO 14971:2019 Medical devices. Application of risk management to medical devices
CAN/CSA-ISO 14971:2001(C2006) Medical devices - Application of risk management to medical devices
MIL MIL-C-42068-1989 CHEST, MEDICAL INSTRUMENT AND SUPPLY SET
AAMI/ISO 10993-16:1997(R2009) Biological evaluation of medical devices Part 16: Toxicokinetic study design for degradation products and leachables from medical devices

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

GSO

BH GSO ISO 22442-1:2017 Medical devices utilizing animal tissues and their derivatives -- Part 1: Application of risk manag ement
GSO ISO 22442-1:2016 Medical devices utilizing animal tissues and their derivatives -- Part 1: Application of risk manag ement
OS GSO ISO 22442-1:2016 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
GSO ISO 22442-2:2016 Medical devices utilizing animal tissues and their derivatives -- Part 2: Controls on sourcing, collection and handling
OS GSO ISO 22442-2:2016 Medical devices utilizing animal tissues and their derivatives -- Part 2: Controls on sourcing, collection and handling
OS GSO IEC 62366:2014 Medical devices - Application of usability engineering to medical devices
BH GSO ISO 14971:2017 Medical devices -- Application of risk management to medical devices
OS GSO ISO 14971:2015 Medical devices -- Application of risk management to medical devices

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
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

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
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

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

ES-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 22442-2:2022 Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020)
UNE-EN ISO 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)

Danish Standards Foundation

DS/ISO 22442-1:2020 Medical devices utilizing animal tissues and their derivatives – Part 1: Application of risk management
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/ISO 22442-2:2020 Medical devices utilizing animal tissues and their derivatives – Part 2: Controls on sourcing, collection and handling
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)
DS/EN 62366:2008 Medical devices - Application of usability engineering to medical devices
DS/EN ISO 14971:2013 Medical devices - Application of risk management to medical devices

DIN

DIN 58239-1:2023 Medical instruments - Tissue forceps - Part 1: Straight
DIN 58239-2:2023 Medical instruments - Tissue forceps - Part 2: Curved
DIN EN 12442-1:2001 Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 1: Analysis and management of risk; English version of DIN EN 12442-1

European Committee for Standardization (CEN)

EN 12442-1:2000 Animal Tissues and Their Derivatives Utilized in the Manufacture of Medical Devices - Part 1: Analysis and Management of Risk
EN 12442-2:2000 Animal Tissues and Their Derivatives Utilized in the Manufacture of Medical Devices - Part 2: Controls on Sourcing, Collection and Handling
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
CENELEC EN 62366-2008 Medical devices - Application of usability engineering to medical devices
EN ISO 22442-1:2020 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020)

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)

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)

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)

British Standards Institution (BSI)

BS EN 62366-1:2015+A1:2020 Medical devices. Application of usability engineering to medical devices
BS EN ISO 22442-1:2008 Medical devices utilizing animal tissues and their derivatives - Application of risk management
BS EN ISO 22442-1:2015 Medical devices utilizing animal tissues and their derivatives. Application of risk management
BS EN ISO 22442-1:2020 Medical devices utilizing animal tissues and their derivatives. Application of risk management
BS EN 62366-1:2015 Medical devices. Application of usability engineering to 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 14160:2011 Sterilization of health care products. Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives. Requirements for characterization, development, validation and routine control of a sterilization proc
BS PD IEC/TR 62366-2:2016 Medical devices. Guidance on the application of usability engineering to medical devices
BS EN ISO 10993-2:2022 Biological evaluation of medical devices - Animal welfare requirements
BS EN ISO 10993-2:2006 Biological evaluation of medical devices - Animal welfare requirements
BS EN ISO 14971:2001 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 ISO 22442-2:2015 Medical devices utilizing animal tissues and their derivatives. Controls on sourcing, collection and handling
BS EN ISO 22442-2:2008 Medical devices utilizing animal tissues and their derivatives - Controls on sourcing, collection and handling
BS EN ISO 22442-2:2020 Medical devices utilizing animal tissues and their derivatives. Controls on sourcing, collection and handling

RU-GOST R

GOST ISO 14971-2011 Medical devices. Application of risk management to medical devices
GOST R IEC 62366-2013 Medical devices. Application of usability engineering to 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
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 ISO/TS 10993-20-2011 Medical devices. Biological evaluation of medical devices. Part 20. Principles and methods for immunotoxicology testing of medical devices

International Organization for Standardization (ISO)

ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
ISO 10993-11:2006 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
ISO 14971:2019 Medical devices — Application of risk management to medical devices
ISO 14971:2000 Medical devices - Application of risk management to medical devices
IEC 62366:2007 Medical devices - Application of usability engineering to medical devices

Korean Agency for Technology and Standards (KATS)

KS P ISO 10993-11:2007 Biological evaluation of medical devices－Part 11：Tests for systemic toxicity
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

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

CEN - European Committee for Standardization

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 14971:2000 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
EN ISO 22442-1:2007 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management

International Electrotechnical Commission (IEC)

IEC 62366:2014 Medical devices - Application of usability engineering to medical devices

ZA-SANS

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

American National Standards Institute （ANSI)

ANSI/AAMI/ISO 14160:2011 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization pr

TH-TISI

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

IN-BIS

IS 12572 Pt.3-1988 Guidelines for Biohazard Assessment of Medical Devices Part 3 Tissue Implantation Test Methods

CENELEC - European Committee for Electrotechnical Standardization

EN 62366:2008 Medical devices - 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

American Society for Testing and Materials (ASTM)

ASTM F561-97(2003) Practice for Retrieval and Analysis of Implanted Medical Devices, and Associated Tissues

Others: Medical Devices for Animals,How are animal tissues preserved?,Animal Tissues for Medical Devices