SFS-EN 12182:2012/AC:2016

Soveltamisala

Tässä eurooppalaisessa standardissa määritellään vammaisten apuvälineiden yleiset vaatimukset ja testime¬netelmät, kun apuvälineitä käytetään EU-direktiivissä 93/42/ETY tarkoitettuina terveydenhuollon laitteina ja tarvikkeina.
Tätä standardia ei sovelleta apuvälineisiin, joiden suunniteltu käyttötarkoitus saavutetaan antamalla käyttä¬jälle lääkeainetta.
Jos tietyntyyppiselle apuvälineelle on olemassa muita eurooppalaisia standardeja, sovelletaan niitä. Joitakin tämän standardin vaatimuksia voidaan kuitenkin soveltaa ja ottaa huomioon muiden eurooppalaisten stan¬dardien ohella.
HUOM. Kaikki standardissa EN ISO 9999 luetellut tuotteet eivät ole terveydenhuollon laitteita ja tarvikkeita. Tätä stan¬dardia tai sen osia voidaan tarvittaessa soveltaa apuvälineisiin, jotka eivät ole terveydenhuollon laitteita ja tarvikkeita EU:n direktiivin 93/42/ETY määritelmän mukaisesti.

Tämän julkaisun valmistelusta Suomessa vastaa Yhteinen Toimialaliitto, www.ytl.fi.

Tuoteryhmä(t)

11.180.01 Vammaisten apuvälineet, yleistä »

Sidokset

Velvoittavat viittaukset

CISPR 11:2009
EN 1021-1:2014 Furniture - Assessment of the ignitability of upholstered furniture - Part 1: Ignition source smouldering cigarette
EN 1021-2:2014 Furniture - Assessment of the ignitability of upholstered furniture - Part 2: Ignition source match flame equivalent

CISPR 11:2009
EN 1021-1:2014 Furniture - Assessment of the ignitability of upholstered furniture - Part 1: Ignition source smouldering cigarette
EN 1021-2:2014 Furniture - Assessment of the ignitability of upholstered furniture - Part 2: Ignition source match flame equivalent
EN 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
EN 597-1:2015 Furniture - Assessment of the ignitability of mattresses and upholstered bed bases - Part 1: Ignition source smouldering cigarette
EN 597-2:2015 Furniture - Assessment of the ignitability of mattresses and upholstered bed bases - Part 2: Ignition source: match flame equivalent
EN 60335-1:2012/A13:2017 Household and similar electrical appliances - Safety - Part 1: General requirements
EN 60529:1991 Sähkölaitteiden kotelointiluokat (IP-koodi)
EN 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
EN 60601-1:2006 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
EN 60695-11-10:2013 Fire hazard testing - Part 11-10: Test flames - 50 W horizontal and vertical flame test methods
EN 60730-1:2016 Automatic electrical controls - Part 1: General requirements
EN 61000-3-3:2013 Electromagnetic compatibility (EMC) - Part 3-3: Limits - Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems, for equipment with rated current <= 16 A per phase and not subject to conditional connection
EN 61000-4-8:2010 Electromagnetic compatibility (EMC) - Part 4-8: Testing and measurement techniques - Power frequency magnetic field immunity test
EN 614-1:2006+A1:2009 Safety of machinery - Ergonomic design principles - Part 1: Terminology and general principles
EN 62304:2006 Medical device software - Software life-cycle processes
EN 80601-2-35:2009 Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use
EN IEC 60601-2-35:2021 Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use
EN IEC 61000-3-2:2019 Electromagnetic compatibility (EMC) - Part 3-2: Limits - Limits for harmonic current emissions (equipment input current =16 A per phase)
EN IEC 62368-1:2020 Audio/video, information and communication technology equipment - Part 1: Safety requirements
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)
EN ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)
EN ISO 11137-1:2015 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)
EN ISO 11137-2:2015 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
EN ISO 11607-1:2020 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
EN ISO 12952-1:2010 Textiles - Assessment of the ignitability of bedding items - Part 1: Ignition source: smouldering cigarette (ISO 12952-1:2010)
EN ISO 12952-2:2010 Textiles - Assessment of the ignitability of bedding items - Part 2: Ignition source: match-flame equivalent (ISO 12952-2:2010)
EN ISO 13732-1:2008 Ergonomics of the thermal environment - Methods for the assessment of human responses to contact with surfaces - Part 1: Hot surfaces (ISO 13732-1:2006)
EN ISO 13850:2015 Safety of machinery - Emergency stop function - Principles for design (ISO 13850:2015)
EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
EN ISO 22442-1:2020 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020)
EN ISO 24415-1:2009 Tips for assistive products for walking - Requirements and test methods - Part 1: Friction of tips (ISO 24415-1:2009)
EN ISO 25424:2019 Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018)
EN ISO 3746:2010 Acoustics - Determination of sound power levels and sound energy levels of noise sources using sound pressure - Survey method using an enveloping measurement surface over a reflecting plane (ISO 3746:2010)
ISO 24415-2:2011 Tips for assistive products for walking -- Requirements and test methods -- Part 2: Durability of tips for crutches
ISO 8986-1:1993 Plastics -- Polybutene (PB) moulding and extrusion materials -- Part 1: Designation system and basis for specifications

Tekninen komitea

CEN/TC 293 Assistive products and accessibility »

Direktiivi

93/42/EEC Lääkinnälliset laitteet
2007/47/EC Aktiiviset implantoitavat lääkinnälliset laitteet

http://ec.europa.eu »

Vahvistuspäivä

26.08.2016

Kumouspäivä

29.07.2022

Painos

1

Sivumäärä

1

Julkaisun kieli

suomi

SFS-EN 12182:2012/AC:2016 Kumottu