EN 552:1994/A2:2000
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION
Superseded date
01-04-2006
Superseded by
Published date
12-01-2013
Publisher
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Foreword
Foreword to amendment A1
Foreword to amendment A2
Introduction
1 Scope
2 Normative references
3 Definitions
4 General
5 Validation
6 Process control and monitoring
7 Product release from sterilization (parametric release)
Annex A (informative) Guidance on the application of EN 552
Annex B (informative) Bibliography
Gives requirements for the validation, process control and monitoring of the radiation sterilization of medical devices. Specifies the requirements which ensure that a predetermined dose is consistently absorbed by product presented to the sterilization process. Does not cover radiation protection requirements associated with operating irradiation plants.
| Committee |
TC 204
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| NBN EN 552 : 95 AMD 2 2001 | Identical |
| NF EN 552 : 94 AMD 2 2001 | Identical |
| NEN EN 552 : 1995 AMD 2 2001 | Identical |
| NS EN 552 : 94 AMD 2 2001 | Identical |
| I.S. EN 552:1994 | Identical |
| SN EN 552 : 1995 AMD 2 2001 | Identical |
| UNI EN 552 : 2002 | Identical |
| DIN EN 552:2001-02 | Identical |
| DIN EN 552:1994-11 | Identical |
| 03/108542 DC : DRAFT MAY 2003 | BS EN ISO 11140-1 - STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS |
| I.S. EN 1283:1996 | HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS, HAEMOCONCENTRATORS AND THEIR EXTRACORPOREAL CIRCUITS |
| I.S. EN 13824:2005 | STERILIZATION OF MEDICAL DEVICES - ASEPTIC PROCESSING OF LIQUID MEDICAL DEVICES - REQUIREMENTS |
| I.S. EN 12022:1999 | BLOOD GAS EXCHANGERS |
| I.S. EN 13503-8:2000 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS |
| PREN ISO 11140-1 : DRAFT 2012 | STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS (ISO/DIS 11140-1:2012) |
| 03/103294 DC : DRAFT JAN 2003 | BS EN ISO 10651-6 - LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME CARE VENTILATORY SUPPORT DEVICES |
| 02/563808 DC : DRAFT SEP 2002 | BS EN 1639 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS |
| CSA Z10651.6 : 2006 : R2015 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES |
| CSA Z11140.1 : 2007 : R2012 | STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS |
| CSA C22.2 No. 60601.2.12 : 2003 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS |
| DIN EN ISO 11140-1:2015-03 | Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014) |
| BS EN 724:1995 | Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for non-active medical devices |
| BS EN 556-1:2001 | Sterilization of medical devices. Requirements for medical devices to be designated \'STERILE\' Part 1. Requirements for terminally sterilized medical devices |
| BS EN 1283:1996 | Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits |
| BS EN ISO 11140-1:2014 | Sterilization of health care products. Chemical indicators General requirements |
| BS EN 794-2:1997 | Lung ventilators Particular requirements for home care use |
| BS EN 13824:2004 | Sterilization of medical devices. Aseptic processing of liquid medical devices. Requirements |
| EN 12011 : 1998 | INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
| EN 13503-8 : 2000 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS |
| EN 12442-3 : 2000 | ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE AGENTS |
| EN 12022:1999 | Blood gas exchangers |
| EN ISO 11140-1:2014 | Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014) |
| EN 13544-1:2007+A1:2009 | Respiratory therapy equipment - Part 1: Nebulizing systems and their components |
| EN 1283:1996 | Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits |
| I.S. EN 14820:2004 | SINGLE-USE CONTAINERS FOR HUMAN VENOUS BLOOD SPECIMEN COLLECTION |
| I.S. EN 12442-3:2000 | ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE AGENTS |
| 12/30238553 DC : 0 | BS EN ISO 11140-1 - STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS |
| BS EN 45502-2-3:2010 | Active implantable medical devices Particular requirements for cochlear and auditory brainstem implant systems |
| I.S. EN 556-1:2002 | STERILISATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED STERILE - PART 1: REQUIREMENTS FOR TERMINALLY STERILISED MEDICAL DEVICES |
| BS EN 1174-1:1996 | Sterilization of medical devices. Estimation of the population of micro-organisms on product Requirements |
| I.S. EN ISO 11140-1:2014 | STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS (ISO 11140-1:2014) |
| DIN EN 794-1:2001-02 | LUNG VENTILATORS - PART 1: PARTICULAR REQUIREMENTS FOR CRITICAL CARE VENTILATORS |
| I.S. EN 794-3:1998 | LUNG VENTILATORS - PART 3: PARTICULAR REQUIREMENTS FOR EMERGENCY AND TRANSPORT VENTILATORS |
| I.S. EN ISO 10651-6:2009 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES |
| DIN EN ISO 10651-2:2011-06 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS |
| I.S. EN 12442-1:2000 | ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK |
| 01/563350 DC : DRAFT AUG 2001 | BS ISO 25539-1 - CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES |
| 01/564180 DC : DRAFT OCT 2001 | BS EN 14254 - IN VITRO DIAGNOSTIC MEDICAL DEVICES - SINGLE-USE RECEPTACLES FOR THE COLLECTION OF SPECIMENS, OTHER THAN BLOOD, FROM HUMANS |
| 02/560165 DC : DRAFT JAN 2002 | BS EN 556-2 - STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED 'STERILE' - PART 2: REQUIREMENTS FOR ASEPTICALLY PROCESSED MEDICAL DEVICES |
| BS 5724-2.202(1997) : 1997 + A2 2009 | LUNG VENTILATORS - PART 1: PARTICULAR REQUIREMENTS FOR CRITICAL CARE VENTILATORS |
| BS ISO 25539-1 : 2003 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES |
| CSA Z10651.6 : 2006 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES |
| CEI EN 60601-2-12 : 2007 | MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS |
| DIN EN ISO 10651-6:2011-06 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES |
| DIN EN 13544-1:2009-12 | RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS |
| BS EN 14820:2004 | Single-use containers for human venous blood specimen collection |
| BS EN 12022:1999 | Blood-gas exchangers |
| UNE-EN ISO 11140-1:2015 | Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014) |
| BS EN 12442-1:2000 | Animal tissues and their derivatives utilized in the manufacture of medical devices Analysis and management of risk |
| I.S. EN 13544-1:2007 | RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS |
| UNI EN ISO 10651-2 : 2009 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR- DEPENDENT PATIENTS |
| UNI EN 13544-1 : 2009 | RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS |
| UNI CEI EN 45502-2-3 : 2010 | ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-3: PARTICULAR REQUIREMENTS FOR COCHLEAR AND AUDITORY BRAINSTEM IMPLANT SYSTEMS |
| UNI EN ISO 10651-6 : 2009 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES |
| UNI EN 794-1 : 2009 | LUNG VENTILATORS - PART 1: PARTICULAR REQUIREMENTS FOR CRITICAL CARE VENTILATORS |
| UNI EN 794-3 : 2009 | LUNG VENTILATORS - PART 3: PARTICULAR REQUIREMENTS FOR EMERGENCY AND TRANSPORT VENTILATORS |
| I.S. EN 794-2:1997 | LUNG VENTILATORS - PARTICULAR REQUIREMENTS FOR HOME CARE USE |
| I.S. EN 1819:1998 | LARYNGOSCOPES FOR TRACHEAL INTUBATION - PARTICULAR REQUIREMENTS |
| I.S. EN 12011:1998 | INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
| BS EN 60601-2-12:2006 | Medical electrical equipment Particular requirements for the safety of lung ventilators. Critical care ventilators |
| MEDDEV 2.5-7 : REV 1 : 1998 | GUIDELINES FOR CONFORMITY ASSESSMENT OF BREAST IMPLANTS ACCORDING TO DIRECTIVE 93/42/EEC RELATING TO MEDICAL DEVICES |
| CEI EN 50103 : 1996 | GUIDANCE ON THE APPLICATION OF EN 29001 AND EN 46001 AND OF EN 29002 AND EN 46002 FOR THE ACTIVE (INCLUDING ACTIVE IMPLANTABLE) MEDICAL DEVICE INDUSTRY |
| 03/103293 DC : DRAFT JAN 2003 | BS EN ISO 10651-2 - LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS |
| BS EN 50103:1996 | Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for the active (including active implantable) medical device industry |
| CSA Z11140.1 : 2007 : R2012 : FR | STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS |
| CSA Z10651.2: 2006 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS |
| CSA Z11140.1 : 2007 | STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS |
| I.S. EN ISO 11607-1:2017 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS (ISO 11607-1:2006, INCLUDING AMD 1:2014) |
| I.S. EN 14254:2004 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - SINGLE-USE RECEPTACLES FOR THE COLLECTION OF SPECIMENS, OTHER THAN BLOOD, FROM HUMANS |
| I.S. EN 60601-2-12:2006 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS |
| ISO 10651-2:2004 | Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 2: Home care ventilators for ventilator-dependent patients |
| BS EN 1615:2000 | Enteral feeding catheters and enteral giving sets for single use and their connectors. Design and testing |
| BS EN ISO 10651-6:2009 | Lung ventilators for medical use. Particular requirements for basic safety and essential performance Home-care ventilatory support devices |
| BS EN 866-4:2000 | Biological systems for testing sterilizers and sterilization processes Particular systems for use in irradiation sterilizers |
| BS EN 13544-1 : 2007 | RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS |
| BS EN 12011:1998 | Instrumentation to be used in association with non-active surgical implants. General requirements |
| BS EN 867-1:1997 | Non-biological systems for use in sterilizers General requirements |
| BS EN 867-2:1997 | Non-biological systems for use in sterilizers Process indicators (Class A) |
| BS EN 928:1996 | Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for in vitro diagnostic medical devices |
| BS EN 14254:2004 | In vitro diagnostic medical devices. Single-use receptacles for the collection of specimens, other than blood, from humans |
| BS EN 13503-8:2000 | Ophthalmic implants. Intraocular lenses Fundamental requirements |
| BS EN 12442-3:2000 | Animal tissues and their derivatives utilized in the manufacture of medical devices Validation of the elimination and/or inactivation of viruses and transmissible agents |
| BS EN ISO 10651-2:2004 | Lung ventilators for medical use. Particular requirements for basic safety and essential performance Home care ventilators for ventilator-dependent patients |
| ISO 10651-6:2004 | Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 6: Home-care ventilatory support devices |
| BS EN 794-3 : 1999 | LUNG VENTILATORS - PART 3: PARTICULAR REQUIREMENTS FOR EMERGENCY AND TRANSPORT VENTILATORS |
| UNE-EN 45502-2-3:2010 | Active implantable medical devices -- Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems |
| EN 556:1994 + A1:1998 | STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR TERMINALLY-STERILIZED MEDICAL DEVICES TO BE LABELLED "STERILE" |
| EN ISO 10651-2:2009 | Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilators for ventilator-dependent patients (ISO 10651-2:2004) |
| EN 866-1 : 1997 | BIOLOGICAL SYSTEMS FOR TESTING STERILIZERS AND STERILIZATION PROCESSES - GENERAL REQUIREMENTS |
| EN ISO 10651-6:2009 | Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 6: Home-care ventilatory support devices (ISO 10651-6:2004) |
| EN 794-2 : 1997 | LUNG VENTILATORS - PARTICULAR REQUIREMENTS FOR HOME CARE USE |
| EN 45502-2-3:2010 | Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems |
| EN 868-1 : 1997 | PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED - GENERAL REQUIREMENTS AND TEST METHODS |
| EN 14820:2004 | Single-use containers for human venous blood specimen collection |
| EN 794-3:1998+A2:2009 | Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators |
| EN 794-1:1997+A2:2009 | Lung ventilators - Part 1: Particular requirements for critical care ventilators |
| EN 13824:2004 | Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements |
| I.S. EN ISO 10651-2:2009 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS |
| 07/30147572 DC : DRAFT SEP 2007 | BS ISO 27427 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS |
| 04/30101211 DC : DRAFT APR 2004 | ISO 11607-1 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS |
| CSA Z10651.2 : 2006 : R2015 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS |
| I.S. EN 45502-2-3:2010 | ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-3: PARTICULAR REQUIREMENTS FOR COCHLEAR AND AUDITORY BRAINSTEM IMPLANT SYSTEMS |
| CSA ISO 11140-1 : 2016 | STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS |
| EN 14254:2004 | In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans |
| DIN EN 794-3:2009-12 | Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators; German version EN 794-3:1998+A2:2009 |
| ISO 11140-1:2014 | Sterilization of health care products Chemical indicators Part 1: General requirements |
| BS EN 868-1:1997 | Packaging materials and systems for medical devices which are to be sterilized General requirements and test methods |
| DIN EN 14820:2004-11 | SINGLE-USE CONTAINERS FOR HUMAN VENOUS BLOOD SPECIMEN COLLECTION |
| EN 12442-1 : 2000 | ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK |
| DIN EN 13824:2005-02 | STERILIZATION OF MEDICAL DEVICES - ASEPTIC PROCESSING OF LIQUID MEDICAL DEVICES - REQUIREMENTS |
| DIN EN 14254:2004-09 | In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans |
| EN 1615:2000 | Enteral feeding catheters and enteral giving sets for single use and their connectors - Design and testing |
| EN 60601-2-12:2006 | Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators |
| UNE-EN 794-3:1999 | LUNG VENTILATORS. PART 3: PARTICULAR REQUIREMENTS FOR EMERGENCY AND TRANSPORT VENTILATORS. |
| EN 556:1994 + A1:1998 | STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR TERMINALLY-STERILIZED MEDICAL DEVICES TO BE LABELLED "STERILE" |
| EN 29002 : 1994 | QUALITY SYSTEMS - MODEL FOR QUALITY ASSURANCE IN PRODUCTION & INSTALLATION |
| EN 46001 : 1996 | QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9001 |
| EN 1174-1 : 1996 | STERILIZATION OF MEDICAL DEVICES - ESTIMATION OF THE POPULATION OF MICRO-ORGANISMS ON PRODUCT - REQUIREMENTS |
| EN 46002 : 1996 | QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9002 |
| EN 29001 : 1994 | QUALITY SYSTEMS - MODEL FOR QUALITY ASSURANCE IN DESIGN/DEVELOPMENT, PRODUCTION, INSTALLATION & SERVICING |
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