EN 455-2:2015
Current
The latest, up-to-date edition.
Medical gloves for single use - Part 2: Requirements and testing for physical properties
29-04-2015
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Dimensions
5 Strength
6 Test report
7 Labelling
Annex ZA (informative) - Relationship between this
European Standard and the Essential
Requirements of EU Directive 93/42/EEC
concerning medical devices
This European Standard specifies requirements and gives test methods for physical properties of single-use medical gloves (i.e. surgical gloves and examination/procedure gloves) in order to ensure that they provide and maintain in use an adequate level of protection from cross contamination for both patient and user.This European Standard does not specify the size of a lot. Attention is drawn to the difficulties that can be associated with the distribution and control of very large lots. The recommended maximum individual lot size for production is 500 000.
| DevelopmentNote |
Supersedes PREN 455-2. (05/2015)
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| UNI EN 455-2 : 2015 | Identical |
| UNE-EN 455-2:2015 | Identical |
| NF EN 455-2 : 2010 + A2 2013 | Identical |
| DIN EN 455-2:2015-07 | Identical |
| PN EN 455-2 : 2015 | Identical |
| SN EN 455-2:2015 | Identical |
| BS EN 455-2:2015 | Identical |
| NEN EN 455-2 : 2015 | Identical |
| UNI EN 455-2 : 2013 | Identical |
| I.S. EN 455-2:2015 | Identical |
| NS-EN 455-2:2015 | Identical |
| NBN EN 455-2 : 2015 | Identical |
| BS 4005:1996 | Similar to |
| NFPA 1999 : 2018 | PROTECTIVE CLOTHING AND ENSEMBLES FOR EMERGENCY MEDICAL OPERATIONS |
| 14/30289772 DC : 0 | BS EN 1789:2007+A1:2010/A2 - MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES |
| 12/30266576 DC : 0 | BS EN 13718-2 - MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS OF AIR AMBULANCES |
| I.S. EN 16844:2017+A2:2019 | Aesthetic medicine services - Non-surgical medical treatments |
| EN 13718-2:2015 | Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances |
| 13/30278952 DC : 0 | BS EN 16372 - AESTHETIC SURGERY AND AESTHETIC NON-SURGICAL MEDICAL SERVICES |
| I.S. EN 16844:2017 | AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES |
| UNI EN 13976-2 : 2011 | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
| UNE-EN 13976-2:2011 | Rescue systems - Transportation of incubators - Part 2: System requirements |
| DIN EN 1789:2014-12 | MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES |
| VDI 2083 Blatt 9.2:2017-01 | Cleanroom technology - Consumables in the cleanroom |
| 15/30317874 DC : 0 | BS EN 16844 - AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES |
| UNE-EN 16372:2015 | Aesthetic surgery services |
| I.S. EN 16372:2014 | AESTHETIC SURGERY SERVICES |
| DIN EN 13976-2:2016-03 (Draft) | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
| EN 16844:2017 | Aesthetic medicine services - Non-surgical medical treatments |
| DIN EN 13718-2:2015-05 | MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES |
| BS EN 13976-2:2011 | Rescue systems. Transportation of incubators System requirements |
| UNE-EN 13718-2:2015 | Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances |
| I.S. EN 1789:2007 | MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES |
| EN 1789:2007+A2:2014 | Medical vehicles and their equipment - Road ambulances |
| UNI EN 13795-1 : 2009 | SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES, FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS |
| PREN 13976-2 : DRAFT 2016 | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
| 16/30333925 DC : 0 | BS EN 13976-2 - RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
| I.S. EN 13976-2:2011 | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
| BS EN 1789 : 2007 | MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES |
| UNE-EN 1789:2007 | Medical vehicles and their equipment - Road ambulances |
| BS EN 13718-2:2015 | Medical vehicles and their equipment. Air ambulances Operational and technical requirements for air ambulances |
| I.S. EN 13718-2:2015 | MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES |
| DIN EN 13976-2 E : 2011 | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
| I.S. EN 13718-2:2015+A1:2020 | MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES |
| EN 16372:2014 | Aesthetic surgery services |
| BS EN 16372:2014 | Aesthetic surgery services |
| BS EN 16844 : 2017 | AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL TREATMENTS |
| EN 13976-2:2011 | Rescue systems - Transportation of incubators - Part 2: System requirements |
| DIN EN 13976-2:2011-08 | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
| UNI EN 1789 : 2014 | MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES |
| ISO 23529:2016 | Rubber General procedures for preparing and conditioning test pieces for physical test methods |
| EN 455-4:2009 | Medical gloves for single use - Part 4: Requirements and testing for shelf life determination |
| ISO 188:2011 | Rubber, vulcanized or thermoplastic — Accelerated ageing and heat resistance tests |
| EN 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
| ISO 15223-1:2016 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
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