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DS/EN ISO 10993-1:2009 (Valid to: 30-06-2021)

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process


Status:
Valid to: 30-06-2021
Type:
Standard
Language:
English
Subject:
Replaced by:
Price from:
€ 74.63
Legislation:

DS/EN ISO 10993-1:2020

Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-11)


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 96.69
Legislation:

Please note that this standard has not yet been harmonised and thus cannot be used for CE marking. Until harmonisation of this standard has been achieved, please use one of the following standards: 


DS/ISO 10993-1:2018

Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process (ISO/FDIS 10993-1:2018)


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 86.06

DS/EN ISO 10993-1/AC:2010 (Valid to: 30-06-2021)

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process


Status:
Valid to: 30-06-2021
Type:
Correction sheet
Language:
English
Subject:
Replaced by:
Price from:
€ 0.00
Legislation:

DS/EN ISO 10993-2:2006

Biological evaluation of medical devices - Part 2: Animal welfare requirements


Status:
Current
Type:
Standard
Language:
English
Subject:
Under revision:
Price from:
€ 61.05

DS/EN ISO 10993-3:2014

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 96.69
Legislation:

DS/EN ISO 10993-4:2017

Biological evaluation of medical devices – Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 113.90
Legislation:

Please note that this standard has not yet been harmonised and thus cannot be used for CE marking. Until harmonisation of this standard has been achieved, please use one of the following standards: 


DS/EN ISO 10993-5:2009

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 96.69
Legislation:

DS/EN ISO 10993-6:2016

Biological evaluation of medical devices – Part 6: Tests for local effects after implantation (ISO 10993-6:2016)


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 86.06
Legislation:

Please note that this standard has not yet been harmonised and thus cannot be used for CE marking. Until harmonisation of this standard has been achieved, please use one of the following standards: 


DS/EN ISO 10993-7:2008

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 123.71
Legislation:

DS/EN ISO 10993-7/AC:2009

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals


Status:
Current
Type:
Correction sheet
Language:
English
Subject:
Price from:
€ 0.00
Legislation:

DS/EN ISO 10993-9:2010

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products


Status:
Current
Type:
Standard
Language:
English
Subject:
Under revision:
Price from:
€ 61.05
Legislation:

DS/EN ISO 10993-10:2013

Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization


Status:
Current
Type:
Standard
Language:
English
Subject:
Under revision:
Price from:
€ 113.90

DS/EN ISO 10993-11:2018

Biological evaluation of medical devices – Part 11: Tests for systemic toxicity (ISO 10993-11:2017)


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 86.06
Legislation:

DS/EN ISO 10993-12:2012

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials


Status:
Current
Type:
Standard
Language:
English
Subject:
Under revision:
Price from:
€ 74.63
Legislation:

DS/EN ISO 10993-13:2010

Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 68.18
Legislation:

DS/EN ISO 10993-14:2009

Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 61.05
Legislation:

DS/EN ISO 10993-15:2009

Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys


Status:
Current
Type:
Standard
Language:
English
Subject:
Under revision:
Price from:
€ 61.05
Legislation:

DS/EN ISO 10993-16:2017

Biological evaluation of medical devices – Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 68.18
Legislation:

DS/EN ISO 10993-17:2009

Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 86.06
Legislation:

DS/EN ISO 10993-18:2020

Biological evaluation of medical devices – Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 113.90
Legislation:

DS/ISO 10993-18:2020

Biologisk vurdering af medicinsk udstyr – Del 18: Kemisk karakterisering af materialer til medicinsk udstyr inden for rammerne af en risikostyringsproces


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 104.75

DS/ISO/TS 10993-19:2020

Biological evaluation of medical devices – Part 19: Physico-chemical, morphological and topographical characterization of materials


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 56.88

DS/ISO/TS 10993-20:2006

Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 61.05

DS/ISO/TR 10993-22:2017

Biological evaluation of medical devices – Part 22: Guidance on nanomaterials


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 104.75

DS/EN ISO 10993-23:2021

Biological evaluation of medical devices – Part 23: Tests for irritation (ISO 10993-23:2021)


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 104.75

DS/ISO 10993-23:2021

Biological evaluation of medical devices – Part 23: Tests for irritation


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 104.75

DS/ISO/TR 10993-33:2015

Biological evaluation of medical devices - Part 33: Guidance on tests to evaluate genotoxicity - Supplement to ISO 10993-3


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 96.69

DS/ISO 13022:2012

Medical products containing viable human cells - Application of risk management and requirements for processing practices


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 96.69

DS/EN ISO 14155:2020

Clinical investigation of medical devices for human subjects – Good clinical practice (ISO 14155:2020)


Status:
Current
Type:
Standard
Language:
Danish/English - English
Subject:
Price from:
€ 144.56
Legislation:

DS/ISO 14155:2020

Clinical investigation of medical devices for human subjects – Good clinical practice


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 113.90

DS/ISO 17593:2007

Clinical laboratory testing and in vitro medical devices - Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 104.75

DS/EN ISO 20776-1:2007 (Valid to: 31-07-2023)

Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1: Reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases


Status:
Valid to: 31-07-2023
Type:
Standard
Language:
English
Subject:
Replaced by:
Price from:
€ 74.63
Legislation:

DS/EN ISO 20776-1:2020

Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices – Part 1: Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases (ISO 20776-1:2019, including Corrected version 2019-12)


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 68.18
Legislation:

Please note that this standard has not yet been harmonised and thus cannot be used for CE marking. Until harmonisation of this standard has been achieved, please use one of the following standards: 


DS/ISO 20776-1:2019

Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices – Part 1: Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases (ISO 20776-1:2019, including Corrected version 2019-12)


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 61.05

DS/EN ISO 20776-2:2007

Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 2: Evaluation of performance of antimicrobial susceptibility test devices


Status:
Current
Type:
Standard
Language:
English
Subject:
Under revision:
Price from:
€ 45.85

DS/ISO/TS 21726:2019

Biological evaluation of medical devices – Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 41.82

DS/EN ISO 22442-1:2020

Medical devices utilizing animal tissues and their derivatives – Part 1: Application of risk management (ISO 22442-1:2020)


Status:
Current
Type:
Standard
Language:
English
Price from:
€ 86.06
Legislation:

DS/ISO 22442-1:2020

Medical devices utilizing animal tissues and their derivatives – Part 1: Application of risk management


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 74.63

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)


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 68.18
Legislation:

DS/ISO 22442-2:2020

Medical devices utilizing animal tissues and their derivatives – Part 2: Controls on sourcing, collection and handling


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 61.05

DS/EN ISO 22442-3:2008

Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 74.63
Legislation:

ISO 10993-7:2008/Amd 1:2019

Applicability of allowable limits for neonates and infants


Status:
Current
Type:
Addendum
Language:
English
Subject:

ISO 10993-9:2019

Biological evaluation of medical devices -- Part 9: Framework for identification and quantification of potential degradation products


Status:
Current
Type:
Standard
Language:
English
Subject:

ISO 10993-12:2021

Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials


Status:
Current
Type:
Standard
Language:
English
Subject:

ISO 10993-15:2019

Biological evaluation of medical devices -- Part 15: Identification and quantification of degradation products from metals and alloys


Status:
Current
Type:
Standard
Language:
English
Subject:

ISO 10993-18:2020

Biological evaluation of medical devices -- Part 18: Chemical characterization of medical device materials within a risk management process


Status:
Current
Type:
Standard
Language:
English
Subject:

ISO 10993-23:2021

Biological evaluation of medical devices -- Part 23: Tests for irritation


Status:
Current
Type:
Standard
Language:
English
Subject:

ISO 14155:2020

Clinical investigation of medical devices for human subjects – Good clinical practice


Status:
Current
Type:
Standard
Language:
English
Subject:

ISO/TS 16782:2016

Clinical laboratory testing – Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 107.45

ISO 20776-1:2019

Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices -- Part 1: Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases


Status:
Current
Type:
Standard
Language:
English
Subject:

ISO/TS 21726:2019

Biological evaluation of medical devices – Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 52.81

ISO 22442-1:2020

Medical devices utilizing animal tissues and their derivatives -- Part 1: Application of risk management


Status:
Current
Type:
Standard
Language:
English
Subject:

ISO 22442-2:2020

Medical devices utilizing animal tissues and their derivatives -- Part 2: Controls on sourcing, collection and handling


Status:
Current
Type:
Standard
Language:
English
Subject:

ISO 22442-3:2007

Medical devices utilizing animal tissues and their derivatives -- Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 107.45

ASTM E2805 - 18

Standard Practice for Measurement of the Biological Activity of Ricin


Status:
Current
Type:
Standard
Language:
English
Price from:
€ 45.90

DS/ISO 10993-9:2019 ( Draft )

Biological evaluation of medical devices – Part 9: Framework for identification and quantification of potential degradation products


Status:
Draft
Type:
Standard
Language:
English
Subject:

DS/ISO 10993-12:2021 ( Draft )

Biological evaluation of medical devices – Part 12: Sample preparation and reference materials


Status:
Draft
Type:
Standard
Language:
English
Subject:

DSF/ISO/DIS 10993-2 ( Draft )

Biological evaluation of medical devices -- Part 2: Animal welfare requirements


Status:
Draft
Type:
Standard
Language:
English
Subject:
Price from:
€ 38.19

DSF/prEN ISO 10993-2 ( Draft )

Biological evaluation of medical devices – Part 2: Animal welfare requirements (ISO/DIS 10993-2:2020)


Status:
Draft
Type:
Standard
Language:
English
Subject:
Price from:
€ 38.19

DSF/EN ISO 10993-7:2008/FprA1 ( Draft )

Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals – Amendment 1 (ISO 10993-7/FDAM 1:2019)


Status:
Draft
Type:
Addendum
Language:
English
Subject:

DSF/FprEN ISO 10993-9 ( Draft )

Biological evaluation of medical devices – Part 9: Framework for identification and quantification of potential degradation products (ISO/FDIS 10993-9:2019)


Status:
Draft
Type:
Standard
Language:
English
Legislation:

DSF/ISO/DIS 10993-10 ( Draft )

Biological evaluation of medical devices -- Part 10: Tests for skin sensitization


Status:
Draft
Type:
Standard
Language:
English
Subject:
Price from:
€ 46.66

DSF/prEN ISO 10993-10 ( Draft )

Biological evaluation of medical devices – Part 10: Tests for skin sensitization (ISO/DIS 10993-10:2020)


Status:
Draft
Type:
Standard
Language:
English
Subject:
Price from:
€ 0.00

DSF/FprEN ISO 10993-12 ( Draft )

Biological evaluation of medical devices – Part 12: Sample preparation and reference materials (ISO/FDIS 10993-12:2020)


Status:
Draft
Type:
Standard
Language:
English
Legislation:

DSF/FprEN ISO 10993-15 ( Draft )

Biological evaluation of medical devices – Part 15: Identification and quantification of degradation products from metals and alloys (ISO/FDIS 10993-15:2019)


Status:
Draft
Type:
Standard
Language:
English
Legislation:

DSF/ISO/DIS 20776-2 ( Draft )

Clinical laboratory testing and in vitro diagnostic test systems – Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test – Part 2: Evaluation of performance of antimicrobial susceptibility test devices against reference broth micro-dilution


Status:
Draft
Type:
Standard
Language:
English
Subject:
Price from:
€ 38.19

DSF/prEN ISO 20776-2 ( Draft )

Clinical laboratory testing and in vitro diagnostic test systems – Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test – Part 2: Evaluation of performance of antimicrobial susceptibility test devices against reference broth micro-dilution (ISO/DIS 20776-2:2021)


Status:
Draft
Type:
Standard
Language:
English
Subject:
Price from:
€ 38.19

ISO/DIS 10993-2 ( Draft )

Biological evaluation of medical devices -- Part 2: Animal welfare requirements


Status:
Draft
Type:
Standard
Language:
Subject:

ISO/DIS 10993-10 ( Draft )

Biological evaluation of medical devices -- Part 10: Tests for skin sensitization


Status:
Draft
Type:
Standard
Language:
Subject:

DS/EN ISO 7405:1997 ( Withdrawn )

Dentistry - Preclinical evaluation of biocompatibility of medical devices used in dentistry - Test methods for dental materials


Status:
Withdrawn
Type:
Standard
Language:
English
Replaced by:
Price from:
€ 61.05

DS/EN ISO 7405:2009 ( Withdrawn )

Dentistry - Evaluation of biocompatibility of medical devices used in dentistry


Status:
Withdrawn
Type:
Standard
Language:
English
Replaced by:
Price from:
€ 86.06

DS/EN ISO 7405/A1:2013 ( Withdrawn )

Dentistry - Evaluation of biocompatibility of medical devices used in dentistry - Amendment 1: Positive control material


Status:
Withdrawn
Type:
Addendum
Language:
English
Replaced by:
Price from:
€ 41.82