BS EN 12182:2012
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Assistive products for persons with disability. General requirements and test methods
Available format(s)
Hardcopy , PDF
Superseded date
07-21-2022
Language(s)
English
Published date
06-30-2012
Publisher
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Materials
6 Emitted sound and vibration
7 Electromagnetic compatibility
8 Electrical safety
9 Overflow, spillage, leakage, and ingress of liquids
10 Surface temperature
11 Sterility
12 Safety of moving parts
13 Prevention of traps for parts of the human body
14 Folding and adjusting mechanisms
15 Carrying handles
16 Assistive products which support or suspend users
17 Portable and mobile assistive products
18 Surfaces, corners, edges and protruding parts
19 Hand held assistive products
20 Small parts
21 Stability
22 Forces in soft tissues of the human body
23 Ergonomic principles
24 Requirements for information supplied by the manufacturer
25 Packaging
26 Test report
Annex A (informative) - European standards for assistive
products for persons with a disability produced or
currently being developed by CEN/TC 293
Annex B (informative) - General recommendations
Annex C (informative) - Cognitive impairment
Annex D (informative) - Environmental and consumer related
requirements
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements of EU
Directive 93/42/EEC on Medical Devices
Bibliography
Defines general requirements and test methods for assistive products for persons with a disability, which are medical devices according to the definition laid down in the EU Directive 93/42/EEC.
This European Standard specifies general requirements and test methods for assistive products for persons with a disability, which are medical devices according to the definition laid down in the EU Directive 93/42/EEC. This European Standard does not apply to assistive products which achieve their intended purpose by administering pharmaceutical substances to the user. Where other European Standards exist for particular types of assistive products then those standards apply. However, some of the requirements of this standard may still apply and may be considered in addition to those in other European standards. NOTE Not all the items listed in EN ISO 9999 are medical devices. Contracting parties may wish to consider if this standard or parts of this standard can be used for assistive products which are not medical devices as defined in the EU Directive 93/42/EEC.
| Committee |
CH/173
|
| DevelopmentNote |
Supersedes 97/563865 DC (05/2005) Supersedes 09/30201992 DC. (06/2012)
|
| DocumentType |
Standard
|
| Pages |
66
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| NBN EN 12182 : 2012 | Identical |
| I.S. EN 12182:2012 | Identical |
| DIN EN 12182:2012-07 | Identical |
| EN 12182:2012 | Identical |
| NF EN 12182 : 2012 | Identical |
| UNE-EN 12182:2000 | Identical |
| UNI EN 12182 : 2012 | Identical |
| NEN EN 12182 : 2012 | Identical |
| NS EN 12182 : 2012 | Identical |
| SN EN 12182:2012 | Identical |
| 05/30140467 DC : DRAFT NOV 2005 | BS 8480 - MEDICAL DEVICES - CHAIRS WITH ELECTRICALLY OPERATED SUPPORT SURFACES - REQUIREMENTS |
| 14/30277275 DC : 0 | BS 5446-3 - FIRE DETECTION AND FIRE ALARM DEVICES FOR DWELLINGS - PART 3: SPECIFICATION FOR FIRE AND CARBON MONOXIDE ALARM SYSTEMS FOR DEAF AND HARD OF HEARING PEOPLE |
| BS 4751:2005 | Mobile sanitary chairs |
| 04/30080998 DC : DRAFT JUL 2004 | BS 4751 - MOBILE SANITARY CHAIRS |
| BS 8480:2006 | Medical devices. Chairs with electrically operated support surfaces. Requirements |
| BS 5446-3:2005 | Fire detection and fire alarm devices for dwellings Specification for smoke alarm kits for deaf and hard of hearing people |
| BS 5446-3:2015 | Detection and alarm devices for dwellings Specification for fire alarm and carbon monoxide alarm systems for deaf and hard of hearing people |
| IEC 61000-4-8 : 2.0 | ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-8: TESTING AND MEASUREMENT TECHNIQUES - POWER FREQUENCY MAGNETIC FIELD IMMUNITY TEST |
| IEC 60950-1:2005+AMD1:2009+AMD2:2013 CSV | Information technology equipment - Safety - Part 1: General requirements |
| 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 |
| SR 001 996 : 6.1.1 | HUMAN FACTORS (HF); AN ANNOTATED BIBLIOGRAPHY OF DOCUMENTS DEALING WITH HUMAN FACTORS AND DISABILITY |
| EN 894-3:2000+A1:2008 | Safety of machinery - Ergonomics requirements for the design of displays and control actuators - Part 3: Control actuators |
| EN 120:1992 | Wood based panels - Determination of formaldehyde content - Extraction method called the perforator method |
| IEC 60127-3:2015 | Miniature fuses - Part 3: Sub-miniature fuse-links |
| ISO 5349-2:2001 | Mechanical vibration Measurement and evaluation of human exposure to hand-transmitted vibration Part 2: Practical guidance for measurement at the workplace |
| EN ISO 9999:2016 | Assistive products for persons with disability - Classification and terminology (ISO 9999:2016) |
| IEC 60127-6:2014 | Miniature fuses - Part 6: Fuse-holders for miniature fuse-links |
| EN 60065:2014/AC:2017-01 | AUDIO, VIDEO AND SIMILAR ELECTRONIC APPARATUS - SAFETY REQUIREMENTS (IEC 60065:2014/COR2:2016) |
| CEN/CLC Guide 6:2014 | Guide for addressing accessibility in standards |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| EN 60127-6:2014 | Miniature fuses - Part 6: Fuse-holders for miniature fuse-links |
| ISO 13732-1:2006 | Ergonomics of the thermal environment — Methods for the assessment of human responses to contact with surfaces — Part 1: Hot surfaces |
| 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 (IEC 61000-3-3:2013) |
| EN 60127-1:2006/A2:2015 | MINIATURE FUSES - PART 1: DEFINITIONS FOR MINIATURE FUSES AND GENERAL REQUIREMENTS FOR MINIATURE FUSE-LINKS |
| EN 716-2:2017 | Furniture - Children's cots and folding cots for domestic use - Part 2: Test methods |
| EN ISO 14155:2011/AC:2011 | CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE (ISO 14155:2011) |
| ISO 24415-2:2011 | Tips for assistive products for walking Requirements and test methods Part 2: Durability of tips for crutches |
| 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 1021-1:2014 | FURNITURE - ASSESSMENT OF THE IGNITABILITY OF UPHOLSTERED FURNITURE - PART 1: IGNITION SOURCE SMOULDERING CIGARETTE |
| EN 60950-1:2006/A2:2013 | INFORMATION TECHNOLOGY EQUIPMENT - SAFETY - PART 1: GENERAL REQUIREMENTS (IEC 60950-1:2005/A2:2013, MODIFIED) |
| EN ISO 13850:2015 | Safety of machinery - Emergency stop function - Principles for design (ISO 13850:2015) |
| EN 717-1:2004 | Wood-based panels - Determination of formaldehyde release - Part 1: Formaldehyde emission by the chamber method |
| IEC 60127-5:2016 | Miniature fuses - Part 5: Guidelines for quality assessment of miniature fuse-links |
| IEC 61000-4-8:2009 | Electromagnetic compatibility (EMC) - Part 4-8: Testing and measurement techniques - Power frequency magnetic field immunity test |
| EN 60127-3:2015 | Miniature fuses - Part 3: Sub-miniature fuse-links |
| EN 60127-2:2014 | Miniature fuses - Part 2: Cartridge fuse-links |
| EN ISO 9227:2017 | Corrosion tests in artificial atmospheres - Salt spray tests (ISO 9227:2017) |
| ISO 25424:2009 | Sterilization of medical devices Low temperature steam and formaldehyde Requirements for development, validation and routine control of a sterilization process for medical devices |
| EN 614-1:2006+A1:2009 | Safety of machinery - Ergonomic design principles - Part 1: Terminology and general principles |
| EN 62304:2006/A1:2015 | MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES (IEC 62304:2006/A1:2015) |
| IEC 60127-1:2006+AMD1:2011+AMD2:2015 CSV | Miniature fuses - Part 1: Definitions for miniature fuses andgeneral requirements for miniature fuse-links |
| ISO 22442-1:2015 | Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management |
| EN ISO 5349-2:2001/A1:2015 | MECHANICAL VIBRATION - MEASUREMENT AND EVALUATION OF HUMAN EXPOSURE TO HAND-TRANSMITTED VIBRATION - PART 2: PRACTICAL GUIDANCE FOR MEASUREMENT AT THE WORKPLACE (ISO 5349 2:2001/AMD 1:2015) |
| 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 |
| 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) |
| IEC 60127-2:2014 | Miniature fuses - Part 2: Cartridge fuse-links |
| EN 61000-4-3 : 2006 AMD 2 2010 | ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-3: TESTING AND MEASUREMENT TECHNIQUES - RADIATED, RADIO-FREQUENCY, ELECTROMAGNETIC FIELD IMMUNITY TEST |
| IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
| EN ISO 22442-1:2015 | Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015) |
| EN ISO 25424:2011 | Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2009) |
| EN 60601-1-2:2015 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
| EN 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
| IEC 62304:2006+AMD1:2015 CSV | Medical device software - Software life cycle processes |
| 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 |
| EN ISO 11137-2:2015 | Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013) |
| ISO 12952-2:2010 | Textiles Assessment of the ignitability of bedding items Part 2: Ignition source: match-flame equivalent |
| 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) |
| EN 1888:2012 | Child care articles - Wheeled child conveyances - Safety requirements and test methods |
| EN ISO 5349-1 : 2001 | MECHANICAL VIBRATION - MEASUREMENT AND EVALUATION OF HUMAN EXPOSURE TO HAND-TRANSMITTED VIBRATION - PART 1: GENERAL REQUIREMENTS (ISO 5349-1:2001) |
| IEC 60529:1989+AMD1:1999+AMD2:2013 CSV | Degrees of protection provided by enclosures (IP Code) |
| EN 61000-4-8:2010 | Electromagnetic compatibility (EMC) - Part 4-8: Testing and measurement techniques - Power frequency magnetic field immunity test |
| EN 62079:2001 | Preparation of instructions - Structuring, content and presentation |
| EN 597-1:2015 | Furniture - Assessment of the ignitability of mattresses and upholstered bed bases - Part 1: Ignition source smouldering cigarette |
| EN 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 11135-1:2007) |
| IEC 60695-11-10:2013 | Fire hazard testing - Part 11-10: Test flames - 50 W horizontal and vertical flame test methods |
| ISO 11137-2:2013 | Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose |
| IEC 61000-4-3:2006+AMD1:2007+AMD2:2010 CSV | Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test |
| EN ISO 12952-1:2010 | Textiles - Assessment of the ignitability of bedding items - Part 1: Ignition source: smouldering cigarette (ISO 12952-1:2010) |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ISO 12952-1:2010 | Textiles Assessment of the ignitability of bedding items Part 1: Ignition source: smouldering cigarette |
| IEC 62079:2001 | Preparation of instructions - Structuring, content and presentation |
| IEC 61000-3-3:2013 RLV | 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 61000-3-2:2014 | Electromagnetic compatibility (EMC) - Part 3-2: Limits - Limits for harmonic current emissions (equipment input current ≤ 16 A per phase) |
| IEC 60127-4:2005+AMD1:2008+AMD2:2012 CSV | Miniature fuses - Part 4: Universal modular fuse-links (UMF) -Through-hole and surface mount types |
| 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 14971:2012 | Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
| ISO 2631-1:1997 | Mechanical vibration and shock — Evaluation of human exposure to whole-body vibration — Part 1: General requirements |
| ISO 9227:2017 | Corrosion tests in artificial atmospheres — Salt spray tests |
| ISO 14155:2011 | Clinical investigation of medical devices for human subjects Good clinical practice |
| IEC 61000-3-3 : 3.0EN+(REDLINE+VERSION) | 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 |
| CISPR 11:2015 RLV | Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement |
| ISO 13850:2015 | Safety of machinery Emergency stop function Principles for design |
| EN 60335-1:2012/A13:2017 | HOUSEHOLD AND SIMILAR ELECTRICAL APPLIANCES - SAFETY - PART 1: GENERAL REQUIREMENTS (IEC 60335-1:2010, MODIFIED) |
| ISO 5349-1:2001 | Mechanical vibration Measurement and evaluation of human exposure to hand-transmitted vibration Part 1: General requirements |
| ISO 9999:2016 | Assistive products for persons with disability Classification and terminology |
| EN 597-2:2015 | Furniture - Assessment of the ignitability of mattresses and upholstered bed bases - Part 2: Ignition source: match flame equivalent |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| EN 60529:1991/AC:2016-12 | DEGREES OF PROTECTION PROVIDED BY ENCLOSURES (IP CODE) (IEC 60529 EDITION 2.2 CORRIGENDUM 2:2015) |
| ISO 11607-1:2006 | Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| EN 80601-2-35:2009/A1:2016 | 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 (IEC 80601-2-35:2009/A1:2016) |
| ISO 24415-1:2009 | Tips for assistive products for walking Requirements and test methods Part 1: Friction of tips |
| EN 60068-2-32:1993 | Basic environmental testing procedures - Part 2: Tests - Test Ed: Free fall |
| 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 60601-1-9:2008/A1:2013 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-9: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR ENVIRONMENTALLY CONSCIOUS DESIGN (IEC 60601-1-9:2007/A1:2013) |
| EN 60127-5:2017 | Miniature fuses - Part 5: Guidelines for quality assessment of miniature fuse-links |
| EN 60127-4:2005/A2:2013 | Miniature fuses - Part 4: Universal modular fuse-links (UMF) - Through-hole and surface mount types |
| IEC 60601-1-9:2007+AMD1:2013 CSV | Medical electrical equipment - Part 1-9: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design |
| EN 980:2008 | Symbols for use in the labelling of medical devices |
| EN 1021-2:2014 | Furniture - Assessment of the ignitability of upholstered furniture - Part 2: Ignition source match flame equivalent |
| EN ISO 10993-1:2009/AC:2010 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010) |
| EN 60730-1:2016 | Automatic electrical controls - Part 1: General requirements |
| IEC 61000-3-2 : 4.0 | ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 3-2: LIMITS - LIMITS FOR HARMONIC CURRENT EMISSIONS (EQUIPMENT INPUT CURRENT <= 16 A PER PHASE) |
| IEC 60730-1:2013+AMD1:2015 CSV | Automatic electrical controls - Part 1: General requirements |
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