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Passive Surgical Implants

Passive Surgical Implants, Total:66 items.

In the international standard classification, Passive Surgical Implants involves: Medical equipment.


Professional Standard - Medicine, Passive Surgical Implants

  • YY/T 0640-2008 Non-active surgical implants-General requirements
  • YY/T 0640-2016 Non-active surgical implants.General requirements
  • YY/T 0640-2016/ISO 14630:2012 General requirements for passive surgical implants
  • YY 0954-2015 Nonactive surgical implants.Type I collagen implants.Specific requirements
  • YY/T 0954-2015 Nonactive surgical implants—Type Ⅰ collagen implants—Specific requirements
  • YY/T 0965-2014 Implants for surgery.Artificial ligaments
  • YY 0647-2008 Non-active surgical implants.Mammary implants—Particular requirements
  • YY/T 0726-2009 Instrumentation for use in association with non-active surgical implants.General requirements
  • YY/T 0919-2014 Non-active surgical implants.Joint replacement implants.Specific requirements for knee-joint replacement implants
  • YY/T 0920-2014 Non-active surgical implants.Joint replacement implants.Specific requirements for hip-joint replacement implants
  • YY/T 0663-2008 Non active surgical implants.Particular requirements for cardiac and vascular implants.Specific requirements for arterial stents

Association Francaise de Normalisation, Passive Surgical Implants

  • NF S94-001*NF EN ISO 14630:2013 Non-active surgical implants - General requirements
  • NF EN ISO 14630:2013 Implants chirurgicaux non actifs - Exigences générales
  • NF EN ISO 14607:2018 Implants chirurgicaux non actifs - Implants mammaires - Exigences particulières
  • NF EN ISO 21534:2009 Implants chirurgicaux non actifs - Implants de remplacement d'articulation - Exigences particulières
  • NF S94-002*NF EN ISO 16061:2021 Instruments for use in association with non-active surgical implants - General requirements
  • NF S94-174*NF EN ISO 21536:2009 Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants
  • NF EN ISO 21536:2009 Implants chirurgicaux non actifs - Implants de remplacement d'articulation - Exigences spécifiques relatives aux implants de remplacement de l'articulation du genou
  • NF EN ISO 21535:2009 Implants chirurgicaux non actifs - Implants de remplacement d'articulation - Exigences spécifiques relatives aux implants de remplacement de l'articulation de la hanche
  • NF S94-174/A1*NF EN ISO 21536/A1:2014 Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants - Amendment 1
  • NF EN ISO 21536/A1:2014 Implants chirurgicaux non actifs - Implants de remplacement d'articulation - Exigences spécifiques relatives aux implants de remplacement de l'articulation du genou - Amendement 1
  • NF EN ISO 21535/A1:2017 Implants chirurgicaux non actifs - Implants de remplacement d'articulation - Exigences spécifiques relatives aux implants de remplacement de l'articulation de la hanche - Amendement 1
  • NF EN 12006-2/IN1:2009 Implants chirurgicaux non actifs - Exigences particulières pour les implants cardio-vasculaires - Partie 2 : prothèses vasculaires y compris les conduits valvulés
  • NF S94-201-2:2009 Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 2 : vascular prostheses including cardiac valve conduits.

International Organization for Standardization (ISO), Passive Surgical Implants

Standard Association of Australia (SAA), Passive Surgical Implants

  • AS ISO 14630:2015 Non-active surgical implants — General requirements
  • AS ISO 14602:2015 Non-active surgical implants — Implants for osteosynthesis — Particular requirements

German Institute for Standardization, Passive Surgical Implants

  • DIN EN ISO 14630:2022-10 Non-active surgical implants - General requirements (ISO/DIS 14630:2022); German and English version prEN ISO 14630:2022 / Note: Date of issue 2022-09-09*Intended as replacement for DIN EN ISO 14630 (2013-03).
  • DIN EN ISO 14630:2013-03 Non-active surgical implants - General requirements (ISO 14630:2012); German version EN ISO 14630:2012 / Note: To be replaced by DIN EN ISO 14630 (2022-10).
  • DIN EN ISO 14602:2012-06 Non-active surgical implants - Implants for osteosynthesis - Particular requirements (ISO 14602:2010); German version EN ISO 14602:2011
  • DIN EN ISO 21534:2009-08 Non-active surgical implants - Joint replacement implants - Particular requirements (ISO 21534:2007); German version EN ISO 21534:2009 / Note: DIN EN ISO 21534 (2007-12) remains valid alongside this standard until 2010-03-21.
  • DIN EN ISO 21536:2021-08 Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO/DIS 21536:2021); German and English version prEN ISO 21536:2021 / Note: Date of issue 2021-07-16*Intended as replacement for DIN ...
  • DIN EN ISO 21535:2021-08 Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO/DIS 21535:2021); German and English version prEN ISO 21535:2021 / Note: Date of issue 2021-07-16*Intended as replacement for DIN E...
  • DIN EN ISO 16061:2021 Instruments for use in association with non-active surgical implants - General requirements (ISO 16061:2021); German version EN ISO 16061:2021

国家药监局, Passive Surgical Implants

  • YY/T 1133-2020 Passive surgical implant combined instrument metal bone drill
  • YY/T 0726-2020 General requirements for devices used with passive surgical implants
  • YY/T 0647-2021 Passive Surgical Implants Specific Requirements for Breast Implants
  • YY 0341.2-2020 Passive Surgical Implants Osteosynthesis and Spinal Implants Part 2: Special Requirements for Spinal Implants
  • YY 0341.1-2020 Passive Surgical Implants Bone Engagement and Spinal Implants Part 1: Special Requirements for Bone Engagement Implants

CEN - European Committee for Standardization, Passive Surgical Implants

  • EN 12010:1998 Non-Active Surgical Implants - Joint Replacement Implants - Particular Requirements

British Standards Institution (BSI), Passive Surgical Implants

  • BS EN ISO 21534:2009 Non-active surgical implants - Joint replacement implants - Particular requirements
  • BS EN 12011:1998 Instrumentation to be used in association with non-active surgical implants - General requirements
  • BS EN ISO 21536:2009 Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants
  • BS EN ISO 21536:2009+A1:2014 Non-active surgical implants. Joint replacement implants. Specific requirements for knee-joint replacement implants

ES-UNE, Passive Surgical Implants

  • UNE-EN ISO 16061:2021 Instruments for use in association with non-active surgical implants - General requirements (ISO 16061:2021)

RU-GOST R, Passive Surgical Implants

  • GOST ISO 14602-2012 Non-active surgical implants. Implants for osteosynthesis. Particular requirements

Korean Agency for Technology and Standards (KATS), Passive Surgical Implants

  • KS P ISO 16061:2008 Instrumentation for use in association with non-active surgical implants-General requirements
  • KS P ISO 16061:2014 Instrumentation for use in association with non-active surgical implants — General requirements

PT-IPQ, Passive Surgical Implants

  • NP EN 12011-2000 Instrumentation to be used in association with non-active surgical implants General requirements

Danish Standards Foundation, Passive Surgical Implants

  • DS/EN ISO 16061:2009 Instrumentation for use in association with non-active surgical implants - General requirements
  • DS/ISO 16061:2021 Instruments for use in association with non-active surgical implants – General requirements
  • DS/EN ISO 16061:2021 Instruments for use in association with non-active surgical implants – General requirements (ISO 16061:2021)
  • DS/ISO/TR 17327-2:2021 Non-active surgical implants – Implant coating – Part 2: Reference standards related to coatings

IT-UNI, Passive Surgical Implants

  • UNI EN ISO 16061:2021 Instruments for use in association with non-active surgical implants - General requirements

European Committee for Standardization (CEN), Passive Surgical Implants

  • EN 12180:2000 Non-Active Surgical Implants - Body Contouring Implants - Specific Requirements for Mammary Implants
  • EN 12006-1:1999 Non-Active Surgical Implants - Particular Requirements for Cardiac and Vascular Implants - Part 1: Heart Valve Substitutes
  • EN 12006-2:1998 Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 2: Vascular prostheses including cardiac valve conduits (Incorporates Amendment A1: 2009)

AT-ON, Passive Surgical Implants

  • OENORM EN ISO 16061:2021 Instruments for use in association with non-active surgical implants - General requirements (ISO 16061:2021)

CH-SNV, Passive Surgical Implants

  • SN EN ISO 16061:2021 Instruments for use in association with non-active surgical implants - General requirements (ISO 16061:2021)

Lithuanian Standards Office , Passive Surgical Implants

  • LST EN ISO 16061:2021 Instruments for use in association with non-active surgical implants - General requirements (ISO 16061:2021)

PL-PKN, Passive Surgical Implants

  • PN-EN ISO 16061-2021-08 E Instruments for use in association with non-active surgical implants -- General requirements (ISO 16061:2021)

国家食品药品监督管理局, Passive Surgical Implants

  • YY/T 1457-2016 Determination of oligomeric siloxanes in passive surgical implants, silicone gel-filled breast implants

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, Passive Surgical Implants

  • GB/T 12417.1-2008 Non-active surgical implants.Osteosynthesis and joint replacement implants.Part 1:Particular requirements for osteosynthesis implants
  • GB/T 12417.2-2008 Non-active surgical implants.Osteosynthesis and joint replacement implants.Part 2:Particular requirements for joint replacement implants




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