PREN 12182 : 2009-06
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
Superseded date
01-05-2012
Published date
01-06-2009
Publisher
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Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Materials
6 Noise, vibration and sound
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 disability produced or currently being
developed by CEN/TC 293
Annex B (informative) General recommendations
Annex C (normative) Ergonomics and cognition
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 Medical Devices
Bibliography
Defines general requirements and test methods for assistive products for persons with disabilities.
| Committee |
TC 293
|
| DocumentType |
Draft
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Superseded
|
| Standards | Relationship |
| 09/30201992 DC : 0 | Identical |
| EN ISO 22523:2006 | External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006) |
| EN 894-3:2000+A1:2008 | Safety of machinery - Ergonomics requirements for the design of displays and control actuators - Part 3: Control actuators |
| 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) |
| EN ISO 8670-2:1996 | Ostomy collection bags - Part 2: Requirements and test methods (ISO 8670-2:1996) |
| EN ISO 16021:2000 | Urine-absorbing aids - Basic principles for evaluation of single-use adult-incontinence-absorbing aids from the perspective of users and caregivers (ISO 16021:2000) |
| EN ISO 22675:2016 | Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675:2016) |
| EN 60065:2014/AC:2017-01 | AUDIO, VIDEO AND SIMILAR ELECTRONIC APPARATUS - SAFETY REQUIREMENTS (IEC 60065:2014/COR2:2016) |
| EN ISO 11334-1:2007 | Assistive products for walking manipulated by one arm - Requirements and test methods - Part 1: Elbow crutches (ISO 11334-1:2007) |
| EN 60127-6:2014 | Miniature fuses - Part 6: Fuse-holders for miniature fuse-links |
| 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 716-2:2017 | Furniture - Children's cots and folding cots for domestic use - Part 2: Test methods |
| EN ISO 12952-2:2010 | Textiles - Assessment of the ignitability of bedding items - Part 2: Ignition source: match-flame equivalent (ISO 12952-2:2010) |
| 2007/47/EC : 2007 COR 1 2015 | DIRECTIVE 2007/47/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 5 SEPTEMBER 2007 AMENDING COUNCIL DIRECTIVE 1990/385/EEC ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO ACTIVE IMPLANTABLE MEDICAL DEVICES, COUNCIL DIRECTIVE 1993/42/EEC CONCERNING MEDICAL DEVICES AND DIRECTIVE 1998/8/EC CONCERNING THE PLACING OF BIOCIDAL PRODUCTS ON THE MARKET(TEXT WITH EEA RELEVANCE) |
| EN ISO 11199-1:1999 | Walking aids manipulated by both arms - Requirements and test methods - Part 1: Walking frames (ISO 11199-1:1999) |
| 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 ISO 11334-4:1999 | Walking aids manipulated by one arm - Requirements and test methods - Part 4: Walking sticks with three or more legs (ISO 11334-4:1999) |
| EN ISO 9227:2017 | Corrosion tests in artificial atmospheres - Salt spray tests (ISO 9227:2017) |
| 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) |
| EN 12182:2012 | Assistive products for persons with disability - General requirements and test methods |
| EN ISO 11199-3:2005 | Walking aids manipulated by both arms - Requirements and test methods - Part 3: Walking tables (ISO 11199-3:2005) |
| EN 1985:1998 | Walking aids - General requirements and test methods |
| 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 61000-4-3 : 2006 AMD 2 2010 | ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-3: TESTING AND MEASUREMENT TECHNIQUES - RADIATED, RADIO-FREQUENCY, ELECTROMAGNETIC FIELD IMMUNITY TEST |
| EN ISO 22442-1:2015 | Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015) |
| 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 |
| EN ISO 10328:2016 | Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO 10328:2016) |
| EN ISO 12952-4 : 1998 | TEXTILES - BURNING BEHAVIOUR OF BEDDING ITEMS - PART 4: SPECIFIC TEST METHODS FOR THE IGNITABILITY BY A SMALL OPEN FLAME |
| EN ISO 11137-2:2015 | Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013) |
| EN 12184:2014 | Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods |
| EN 60601-2-35:1996 | Medical electrical equipment - Part 2: Particular requirements for the safety of blankets, pads and mattresses, intended for heating in medical use |
| 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 10535:2006 | Hoists for the transfer of disabled persons - Requirements and test methods (ISO 10535:2006) |
| EN 15424:2007 | Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices |
| EN 61000-4-8:2010 | Electromagnetic compatibility (EMC) - Part 4-8: Testing and measurement techniques - Power frequency magnetic field immunity test |
| EN 597-1:2015 | Furniture - Assessment of the ignitability of mattresses and upholstered bed bases - Part 1: Ignition source smouldering cigarette |
| EN ISO 11199-2:2005 | Walking aids manipulated by both arms - Requirements and test methods - Part 2: Rollators (ISO 11199-2:2005) |
| 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) |
| EN ISO 12952-1:2010 | Textiles - Assessment of the ignitability of bedding items - Part 1: Ignition source: smouldering cigarette (ISO 12952-1:2010) |
| EN 61000-3-2:2014 | Electromagnetic compatibility (EMC) - Part 3-2: Limits - Limits for harmonic current emissions (equipment input current ≤ 16 A per phase) |
| 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 8669-2:1996 | Urine collection bags - Part 2: Requirements and test methods (ISO 8669-2:1996) |
| 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 |
| CISPR 11:2015 RLV | Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement |
| 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 |
| EN ISO 12952-3 : 1998 | TEXTILES - BURNING BEHAVIOUR OF BEDDING ITEMS - PART 3: GENERAL TEST METHODS FOR THE IGNITABILITY BY A SMALL OPEN FLAME |
| EN 597-2:2015 | Furniture - Assessment of the ignitability of mattresses and upholstered bed bases - Part 2: Ignition source: match flame equivalent |
| EN 60529:1991/AC:2016-12 | DEGREES OF PROTECTION PROVIDED BY ENCLOSURES (IP CODE) (IEC 60529 EDITION 2.2 CORRIGENDUM 2:2015) |
| EN 60068-2-32:1993 | Basic environmental testing procedures - Part 2: Tests - Test Ed: Free fall |
| EN ISO 14184-1:2011 | Textiles - Determination of formaldehyde - Part 1: Free and hydrolysed formaldehyde (water extraction method) (ISO 14184-1:2011) |
| 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 ISO 14155-2:2009 | Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003) |
| EN ISO 14155-1:2009 | Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003) |
| EN 1021-2:2014 | Furniture - Assessment of the ignitability of upholstered furniture - Part 2: Ignition source match flame equivalent |
| IEC 60730-1:2013+AMD1:2015 CSV | Automatic electrical controls - Part 1: General requirements |
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