Customer Support: +353 (0)1 857 6730

Corporate Website About Us
  • Shopping Cart
    There are no items in your cart
Please enter a keyword to search
Advanced search
Home
UNI
UNI EN ISO 14630 : 2013

UNI EN ISO 14630 : 2013

Current

Current

The latest, up-to-date edition.

NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS

Published date

24-01-2013

Publisher

Ente Nazionale Italiano di Unificazione (UNI)

Sorry this product is not available in your region.

PREMESSA
INTRODUZIONE
1 SCOPO E CAMPO DI APPLICAZIONE
2 RIFERIMENTI NORMATIVI
3 TERMINI E DEFINIZIONI
4 PRESTAZIONI PREVISTE
5 ATTRIBUTI DI PROGETTO
6 MATERIALI
7 VALUTAZIONE DEL PROGETTO
8 FABBRICAZIONE
9 STERILIZZAZIONE
10 IMBALLAGGIO
11 INFORMAZIONI FORNITE DAL FABBRICANTE
APPENDICE ZA (informativa) - RAPPORTO FRA LA PRESENTE
             NORMA EUROPEA E I REQUISITI ESSENZIALI
             DELLA DIRETTIVA UE 93/42/CEE
BIBLIOGRAFIA

Defines general requirements for non-active surgical implants, hereafter referred to as implants.

Committee
CT 44
DevelopmentNote
Italian version issued in AUGUST 2013. (08/2013)
DocumentType
Standard
PublisherName
Ente Nazionale Italiano di Unificazione (UNI)
Status
Current
Supersedes

ISO 11137-1:2006 Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
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 process for medical devices
IEC 60068-2-27:2008 Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock
MEDDEV 2.12-1 : REV 8 : 2013 GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM
EN 12006-2:1998+A1:2009 Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 2: Vascular prostheses including cardiac valve conduits
ISO 21534:2007 Non-active surgical implants Joint replacement implants Particular requirements
ISO 5840:2005 Cardiovascular implants Cardiac valve prostheses
ASTM F 2503 : 2013 : REDLINE Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
ISO 14937:2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
CFR 21(PTS800-1299) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
IEC 60601-2-33:2010+AMD1:2013+AMD2:2015 CSV Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
ISO 21536:2007 Non-active surgical implants — Joint replacement implants — Specific requirements for knee-joint replacement implants
IEC 60068-2-31:2008 Environmental testing - Part 2-31: Tests - Test Ec: Rough handling shocks, primarily for equipment-type specimens
ISO 22442-1:2015 Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management
ISO 11135-1:2007 Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO/TR 14283:2004 Implants for surgery Fundamental principles
ISO/IEC Guide 51:2014 Safety aspects — Guidelines for their inclusion in standards
ISO 14602:2010 Non-active surgical implants — Implants for osteosynthesis — Particular requirements
ASTM F 2052 : 2015 : REDLINE Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
IEC 60068-2-47:2005 Environmental testing - Part 2-47: Test - Mounting of specimens for vibration, impact and similar dynamic tests
ISO 16061:2015 Instrumentation for use in association with non-active surgical implants General requirements
ISO 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
ISO 13408-1:2008 Aseptic processing of health care products — Part 1: General requirements
ASTM F 2213 : 2017 : REDLINE Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
ISO 11137-2:2013 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 22442-2:2015 Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling
ISO 25539-3:2011 Cardiovascular implants — Endovascular devices — Part 3: Vena cava filters
ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
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
ISO 7197:2006 Neurosurgical implants — Sterile, single-use hydrocephalus shunts and components
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 14607:2007 Non-active surgical implants Mammary implants Particular requirements
ISO 17664:2017 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
ISO 12891-1:2015 Retrieval and analysis of surgical implants Part 1: Retrieval and handling
ISO 21535:2007 Non-active surgical implants — Joint replacement implants — Specific requirements for hip-joint replacement implants
ISO 17665-1:2006 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 16429:2004 Implants for surgery — Measurements of open-circuit potential to assess corrosion behaviour of metallic implantable materials and medical devices over extended time periods

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.

Get in touch with us