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DS/EN 302 510 V2.1.1:2017

Short Range Devices (SRD); Ultra Low Power Active Medical Membrane Implants (ULP-AMI-M) and Peripherals (ULP-AMI-M-P) operating in the frequency range 30 MHz to 37,5 MHz; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU


Status:
Current
Type:
Standard
Language:
English
Price from:
€ 19.50

DS/EN ISO 5832-1:2019

Implants for surgery – Metallic materials – Part 1: Wrought stainless steel (ISO 5832-1:2016)


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

DS/EN ISO 5832-2:2018

Implants for surgery – Metallic materials – Part 2: Unalloyed titanium (ISO 5832-2:2018)


Status:
Current
Type:
Standard
Language:
English
Price from:
€ 45.85

DS/EN ISO 5832-3:2016

Implants for surgery – Metallic materials – Part 3: Wrought titanium 6-aluminium 4-vanadium alloy (ISO 5832-3:2016)


Status:
Current
Type:
Standard
Language:
English
Under revision:
Price from:
€ 56.88

DS/ISO 5832-4:2014

Implants for surgery - Metallic materials - Part 4: Cobalt-chromium-molybdenum casting alloy


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

DS/ISO 5832-5:2005

Implants for surgery – Metallic materials – Part 5: Wrought cobalt-chromium-tungsten-nickel alloy


Status:
Current
Type:
Standard
Language:
English
Subject:
Under revision:
Price from:
€ 34.56

DS/EN ISO 5832-6:2019

Implants for surgery – Metallic materials – Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy (ISO 5832-6:1997)


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

DS/EN ISO 5832-7:2019

Implants for surgery – Metallic materials – Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy (ISO 5832-7:2016)


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

DS/ISO 5832-9:2019

Implants for surgery – Metallic materials – Part 9: Wrought high nitrogen stainless steel


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

DS/ISO 5832-11:2014

Implants for surgery - Metallic materials - Part 11: Wrought titanium 6-aluminium 7-niobium alloy


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

DS/ISO 5832-12:2019

Implants for surgery – Metallic materials – Part 12: Wrought cobalt-chromium-molybdenum alloy


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

DS/ISO 5832-14:2019

Implants for surgery – Metallic materials – Part 14: Wrought titanium 15-molybdenum 5-zirconium 3-aluminium alloy


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

DS/ISO 5833:2014

Implants for surgery - Acrylic resin cements


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 68.17

DS/ISO 5834-1:2019

Implants for surgery – Ultra-high-molecular-weight polyethylene – Part 1: Powder form


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

DS/ISO 5834-2:2019

Implants for surgery – Ultra-high-molecular-weight polyethylene – Part 2: Moulded forms


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

DS/ISO 5834-3:2019

Implants for surgery – Ultra-high-molecular-weight polyethylene – Part 3: Accelerated ageing methods


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

DS/ISO 5834-4:2019

Implants for surgery – Ultra-high-molecular-weight polyethylene – Part 4: Oxidation index measurement method


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

DS/ISO 5834-5:2019

Implants for surgery – Ultra-high-molecular-weight polyethylene – Part 5: Morphology assessment method


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

DS/ISO 5835:2014

Implants for surgery - Metal bone screws with hexagonal drive connection, spherical under-surface of head, asymmetrical thread - Dimensions


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

DS/ISO 5836:2014

Implants for surgery - Metal bone plates - Holes corresponding to screws with asymmetrical thread and spherical under-surface


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 34.56

DS/ISO 5838-1:2014

Implants for surgery - Metallic skeletal pins and wires - Part 1: General requirements


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 34.56

DS/ISO 5838-2:2014

Implants for surgery - Skeletal pins and wires - Part 2: Steinmann skeletal pins - Dimensions


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 26.22

DS/ISO 5838-3:2014

Implants for surgery - Skeletal pins and wires - Part 3: Kirschner skeletal wires


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 34.56

DS/EN ISO 5840-1:2015 (Valid to: 31-08-2021)

Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements


Status:
Valid to: 31-08-2021
Type:
Standard
Language:
English
Subject:
Replaced by:
Price from:
€ 104.74

DS/ISO 5840-1:2021

Cardiovascular implants – Cardiac valve prostheses – Part 1: General requirements


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 113.89

DS/EN ISO 5840-1:2021

Cardiovascular implants – Cardiac valve prostheses – Part 1: General requirements (ISO 5840-1:2021)


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 113.89

DS/EN ISO 5840-2:2015 (Valid to: 31-08-2021)

Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes


Status:
Valid to: 31-08-2021
Type:
Standard
Language:
English
Subject:
Replaced by:
Price from:
€ 104.74
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 5840-2:2021

Cardiovascular implants – Cardiac valve prostheses – Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2021)


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 104.74
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 5840-2:2021

Cardiovascular implants – Cardiac valve prostheses – Part 2: Surgically implanted heart valve substitutes


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 104.74

DS/EN ISO 5840-3:2013 (Valid to: 31-08-2021)

Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques


Status:
Valid to: 31-08-2021
Type:
Standard
Language:
English
Subject:
Replaced by:
Price from:
€ 136.47

DS/EN ISO 5840-3:2021

Cardiovascular implants – Cardiac valve prostheses – Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2021)


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 104.74

DS/ISO 5840-3:2021

Cardiovascular implants – Cardiac valve prostheses – Part 3: Heart valve substitutes implanted by transcatheter techniques


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 104.74

DS/ISO 5841-2:2014

Implants for surgery - Cardiac pacemakers - Part 2: Reporting of clinical performance of populations of pulse generators or leads


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 68.17

DS/ISO 5910:2018

Cardiovascular implants and extracorporeal systems – Cardiac valve repair devices


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 136.47

DS/ISO 6474-1:2019

Implants for surgery – Ceramic materials – Part 1: Ceramic materials based on high purity alumina


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

DS/ISO 6474-2:2019

Implants for surgery – Ceramic materials – Part 2: Composite materials based on a high-purity alumina matrix with zirconia reinforcement


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

DS/ISO 6475:20014

Implants for surgery - Metal bone screws with asymmetrical thread and spherical under-surface - Mechanical requirements and test methods


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

DS/EN ISO 7197:2009

Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components


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

DS/EN ISO 7198:2017

Cardiovascular implants and extracorporeal systems – Vascular prostheses – Tubular vascular grafts and vascular patches (ISO 7198:2016)


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 104.74
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 7199:2017

Cardiovascular implants and artificial organs – Blood-gas exchangers (oxygenators) (ISO 7199:2016)


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 74.62

DS/EN ISO 7199:2017/A1:2020

Cardiovascular implants and artificial organs – Blood-gas exchangers (oxygenators) – Amendment 1: Connectors (ISO 7199:2016/Amd 1:2020)


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

DS/ISO 7206-1:2014

Implants for surgery - Partial and total hip joint prostheses - Part 1: Classification and designation of dimensions


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 61.04

DS/ISO 7206-2:2014

Implants for surgery - Partial and total hip joint prostheses - Part 2: Articulating surfaces made of metallic, ceramic and plastics materials


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

DS/ISO 7206-2:2011/Amd 1:2016

Implants for surgery – Partial and total hip joint prostheses – Part 2: Articulating surfaces made of metallic, ceramic and plastics materials AMENDMENT 1


Status:
Current
Type:
Addendum
Language:
English
Subject:
Price from:
€ 34.56

DS/ISO 7206-4:2014

Implants for surgery - Partial and total hip joint prostheses - Part 4: Determination of endurance properties and performance of stemmed femoral components


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

DS/ISO 7206-4:2010/Amd 1:2016

Implants for surgery - Partial and total hip joint prostheses - Part 4: Determination of endurance properties and performance of stemmed femoral components AMENDMENT 1


Status:
Current
Type:
Addendum
Language:
English
Subject:
Price from:
€ 34.56

DS/ISO 7206-6:2014

Implants for surgery - Partial and total hip joint prostheses - Part 6: Endurance properties testing and performance requirements of neck region of stemmed femoral components


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 61.04

DS/ISO 7206-10:2018

Implants for surgery – Partial and total hip-joint prostheses – Part 10: Determination of resistance to static load of modular femoral heads


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

DS/ISO 7206-12:2016

Implants for surgery – Partial and total hip joint prostheses – Part 12: Deformation test method for acetabular shells


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

DS/ISO 7206-13:2016

Implants for surgery – Partial and total hip joint prostheses – Part 13: Determination of resistance to torque of head fixation of stemmed femoral components


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

DS/ISO 7207-1:2014

Implants for surgery - Components for partial and total knee joint prostheses - Part 1: Classification, definitions and designation of dimensions


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

DS/ISO 7207-2:2014

Implants for surgery - Components for partial and total knee joint prostheses - Part 2: Articulating surfaces made of metal, ceramic and plastics materials


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 34.56

DS/ISO 7207-2:2011/Amd 1:2016

Implants for surgery – Components for partial and total knee joint prostheses – Part 2: Articulating surfaces made of metal, ceramic and plastics materials AMENDMENT 1


Status:
Current
Type:
Addendum
Language:
English
Subject:
Price from:
€ 34.56

DS/ISO 7207-2:2011/Amd 2:2020

Implants for surgery – Components for partial and total knee joint prostheses – Part 2: Articulating surfaces made of metal, ceramic and plastics materials – AMENDMENT 2


Status:
Current
Type:
Addendum
Language:
English
Subject:
Price from:
€ 34.56

DS/ISO 8319-1:2014

Orthopaedic instruments - Drive connections - Part 1: Keys for use with screws with hexagon socket heads


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

DS/ISO 8319-2:2014

Orthopaedic instruments - Drive connections - Part 2: Screwdrivers for single slot head screws, screws with cruciate slot and cross-recessed head screws


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

DS/ISO 8548-1:2014

Prosthetics and orthotics - Limb deficiencies - Part 1: Method of describing limb deficiencies present at birth


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

DS/ISO 8548-3:2014

Prosthetics and orthotics - Limb deficiencies - Part 3: Method of describing upper limb amputation stumps


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

DS/ISO 8548-4:2014

Prosthetics and orthotics - Limb deficiencies - Part 4: Description of causal conditions leading to amputation


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

DS/ISO 8548-5:2014

Prosthetics and orthotics - Limb deficiencies - Part 5: Description of the clinical condition of the person who has had an amputation


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 34.56

DS/ISO 8549-1:2020

Prosthetics and orthotics – Vocabulary – Part 1: General terms for external limb prostheses and external orthoses


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

DS/ISO 8549-2:2020

Prosthetics and orthotics – Vocabulary – Part 2: Terms relating to external limb prostheses and wearers of these prostheses


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

DS/ISO 8549-3:2020

Prosthetics and orthotics – Vocabulary – Part 3: Terms relating to orthoses


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

DS/ISO 8615:2014

Implants for surgery - Fixation devices for use in the ends of the femur in adults


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

DS/EN ISO 8637:2014 (Valid to: 30-04-2023)

Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators


Status:
Valid to: 30-04-2023
Type:
Standard
Language:
English
Subject:
Replaced by:
Price from:
€ 74.62

DS/EN ISO 8637-1:2020

Extracorporeal systems for blood purification – Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 74.62

DS/EN ISO 8637-2:2018

Extracorporeal systems for blood purification – Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8637-2:2018)


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 74.62