EN 455-3:2015
Withdrawn
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
Withdrawn date
31-10-2015
Published date
01-04-2015
Publisher
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This part of EN 455 specifies requirements for the evaluation of biological safety for medical gloves for single use. It gives requirements for labelling and the disclosure of information relevant to the test methods used.
| Committee |
CEN/TC 205
|
| DevelopmentNote |
Supersedes PREN 455-3. (04/2015)
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Withdrawn
|
| Supersedes |
| Standards | Relationship |
| UNI EN 455-3:2015 | Identical |
| I.S. EN 455-3:2015 | Identical |
| SN EN 455-3 : 2015 | Identical |
| 16/30343252 DC : 0 | Identical |
| UNI EN 455-3 : 2007 | Identical |
| UNE-EN 455-3:2015 | Identical |
| PN EN 455-3 : 2015 | Identical |
| NS-EN 455-3:2015 | Identical |
| 16/30343252 DC : DRAFT OCT 2016 | Identical |
| NS EN 455-3 : 1999 | Identical |
| BS EN 455-3:2015 | Identical |
| NBN EN 455-3 : 2015 | Identical |
| NF EN 455-3 : 2015 | Identical |
| NEN EN 455-3 : 2015 | Identical |
| DIN EN 455-3:2015-07 | Identical |
| DS EN 455-3 : 2015 | Identical |
| ONORM EN 455-3 : 2015 | Identical |
| DD ISO/TS 10993-19:2006 | Biological evaluation of medical devices Physico-chemical, morphological and topographical characterization of materials |
| 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 | AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES |
| I.S. EN 16844:2017+A2:2019 | Aesthetic medicine services - Non-surgical medical treatments |
| NF EN 420 : 2004 + A1 2010 | PROTECTIVE GLOVES - GENERAL REQUIREMENTS AND TEST METHODS |
| EN 13718-2:2015 | Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances |
| BS EN 420 : 2003 | PROTECTIVE GLOVES - GENERAL REQUIREMENTS AND TEST METHODS |
| UNI CEN ISO/TR 16178 : 2014 | FOOTWEAR - CRITICAL SUBSTANCES POTENTIALLY PRESENT IN FOOTWEAR AND FOOTWEAR COMPONENTS |
| DIN EN 15946:2011-11 | Conservation of cultural property - Packing principles for transport |
| 13/30278952 DC : 0 | BS EN 16372 - AESTHETIC SURGERY AND AESTHETIC NON-SURGICAL MEDICAL SERVICES |
| 04/30050436 DC : DRAFT JUN 2004 | BS ISO 22613 - PROTECTIVE CLOTHING - GENERAL TEST METHODS AND PERFORMANCE REQUIREMENTS FOR HAND PROTECTION |
| 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 |
| AAMI BE83 : 2006 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS |
| ISO 16038:2017 | Male condoms — Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms |
| DIN EN ISO 10993-18:2009-08 | Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005); German version EN ISO 10993-18:2009 |
| UNI EN ISO 10993-18 : 2009 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS |
| I.S. EN 420:2003 | PROTECTIVE GLOVES - GENERAL REQUIREMENTS AND TEST METHODS |
| 09/30201447 DC : 0 | BS EN 15946 - CONSERVATION OF CULTURAL PROPERTY - PACKING METHODS |
| 15/30317874 DC : 0 | BS EN 16844 - AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES |
| 16/30346829 DC : 0 | BS ISO 16038 - MALE CONDOMS - GUIDANCE ON THE USE OF ISO 4074 AND ISO 23409 IN THE QUALITY MANAGEMENT CONDOMS |
| BS ISO 16038:2017 | Male condoms. Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms |
| 16/30333925 DC : 0 | BS EN 13976-2 - RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
| ANSI/AAMI/ISO TIR10993-19:2006 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 19: PHYSICOCHEMICAL, MORPHOLOGICAL, AND TOPOGRAPHICAL CHARACTERIZATION OF MATERIALS |
| UNE-EN 16372:2015 | Aesthetic surgery services |
| PD CEN ISO/TR 16178:2012 | Footwear. Critical substances potentially present in footwear and footwear components |
| S.R. CEN ISO/TR 16178:2012 | FOOTWEAR - CRITICAL SUBSTANCES POTENTIALLY PRESENT IN FOOTWEAR AND FOOTWEAR COMPONENTS (ISO/TR 16178:2012) |
| I.S. EN 16372:2014 | AESTHETIC SURGERY SERVICES |
| EN 16844:2017 | Aesthetic medicine services - Non-surgical medical treatments |
| ISO 10993-18:2005 | Biological evaluation of medical devices Part 18: Chemical characterization of materials |
| DIN EN 13718-2:2015-05 | MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES |
| BS EN 15946:2011 | Conservation of cultural property. Packing principles for transport |
| BS EN ISO 10993-18:2009 | Biological evaluation of medical devices Chemical characterization of materials |
| 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 ISO 10993-18:2009 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS (ISO 10993-18:2005) |
| EN 420:2003+A1:2009 | Protective gloves - General requirements and test methods |
| EN ISO 10993-18:2009 | Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005) |
| UNI EN 420 : 2010 | PROTECTIVE GLOVES - GENERAL REQUIREMENTS AND TEST METHODS |
| UNI EN 15946 : 2011 | CONSERVATION OF CULTURAL PROPERTY - PACKING PRINCIPLES FOR TRANSPORT |
| 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 |
| ASTM D 7102 : 2017 : REDLINE | Standard Guide for Determination of Endotoxin on Sterile Medical Gloves |
| ISO/TS 10993-19:2006 | Biological evaluation of medical devices Part 19: Physico-chemical, morphological and topographical characterization of materials |
| I.S. EN 13976-2:2011 | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
| CEN ISO/TR 16178:2012 | Footwear - Critical substances potentially present in footwear and footwear components (ISO/TR 16178:2012) |
| DIN EN 420:2010-03 | PROTECTIVE GLOVES - GENERAL REQUIREMENTS AND TEST METHODS |
| UNE-EN 15946:2016 | Conservation of cultural property - Packing principles for transport. |
| BS EN 13718-2:2015 | Medical vehicles and their equipment. Air ambulances Operational and technical requirements for air ambulances |
| ISO/TR 16178:2012 | Footwear Critical substances potentially present in footwear and footwear components |
| I.S. EN 13718-2:2015 | MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES |
| 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 |
| EN 15946:2011 | Conservation of cultural property - Packing principles for transport |
| BS EN 16372:2014 | Aesthetic surgery services |
| 03/100426 DC : DRAFT JAN 2003 | BS EN ISO 10993-18 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS |
| ANSI/AAMI BE83:2006(R2011) | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS |
| 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 13976-2:2016-03 (Draft) | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
| DIN EN 13976-2:2011-08 | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
| EN ISO 10993-5:2009 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009) |
| EN ISO 10993-10:2013 | Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010) |
| ASTM D 5712 : 2015 : REDLINE | Standard Test Method for Analysis of Aqueous Extractable Protein in Latex, Natural Rubber, and Elastomeric Products Using the Modified Lowry Method |
| EN 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
| ISO 10993-10:2010 | Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| EN ISO 21171:2006 | Medical gloves - Determination of removable surface powder (ISO 21171:2006) |
| EN ISO 14971:2012 | Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 21171:2006 | Medical gloves — Determination of removable surface powder |
| ISO 15223-1:2016 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
| ASTM D 7427 : 2016 : REDLINE | Standard Test Method for Immunological Measurement of Four Principal Allergenic Proteins (Hev b 1, 3, 5 and 6.02) in Hevea Natural Rubber and Its Products Derived from Latex |
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