| Reference |
Title of Standard |
Price |
Buy One Now |
Add One To Basket |
| EN
375:2001 |
Information supplied by the manufacturer with in vitro diagnostic reagents for professional use |
$98.00 |
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| EN
376:2002 |
Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing |
$98.00 |
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| EN
556-1:2001 |
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices |
$89.00 |
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| EN
591:2001 |
Instructions for use for in vitro diagnostic instruments for self-testing |
$89.00 |
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| EN
592:2002 |
Instructions for use for in vitro diagnostic instruments for self-testing |
$89.00 |
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| EN
794-1:1997 |
Lung ventilators - Part 1: Particular requirements for critical care ventilators
EN 794-1:1997/A1:2000 |
$181.00 |
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EN 980:2003 |
Graphical symbols for use in the labelling of madical devices |
$105.00 |
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| EN
1280-1:1997 |
Agent spcific filling systems for anaethetic vaporizers - Part1:
Rectrangular keyed filling systems
EN1280-1:1997/A1:2000 |
$98.00 |
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EN/ ISO 4135:2001 |
Anaethetic and respiratory equipment - Vocabulary (ISO 4135:2001) |
$239.00 |
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| EN
12286:1998 |
In
vitro diagnostic medical devices - Measurement of quantities in
samples of biological origin - Presentation of reference measurement
procedures |
$98.00 |
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| EN
12287:1999 |
In
vitro diagnostic medical devices - Measurement of quantities in
samples of biological origin - Description of reference materials |
$98.00 |
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| EN
12322:1999 |
In
vitro diagnostic medical devices - Culture media for microbiology -
Performance criteria for culture media |
$70.00 |
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EN/ ISO 13485:2003 |
Medical Devices - Quality management systems - Requirements for regulatory purpose (ISO 13485:2003) |
Call For Quote |
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| EN
13532:2002 |
General requirements for in vitro diagnostic medical devices |
$89.00 |
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| EN
13612:2002 |
Performance evaluation of in vitro diagnostic medical devices |
$105.00 |
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| EN
13640:2002 |
Stability testing of in vitro diagnostic reagents |
$89.00 |
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| EN
13641:2002 |
Elimination or reduction of risk of infection related to in vitro diagnostic reagents |
$89.00 |
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| EN
13975:2003 |
Sampling procedures used for risk of infection related to in vitro diagnostic medical devices - Statistical aspects |
$105.00 |
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| EN
14254:2004 |
In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans |
$105.00 |
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| EN
14820:2004 |
Single-use containers for human venous blood specimen collection |
$105.00 |
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EN/ ISO 14937:2000 |
Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of sterilization process for medical devices (ISO 14937:2000) |
$219.00 |
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EN/ ISO 14971:2000 |
Medical Devices - Application of risk management ro medical devices (ISO 14971:2000)
EN ISO 14971:2000/A1:2003 |
$89.00 |
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EN/ ISO 15197:2003 |
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systens fir self-testing in managing diabetes melitus (ISO 15197:2003) |
$205.00 |
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EN/ ISO 15225:2000 |
Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (ISO 15225:2000) |
$158.00 |
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EN/ ISO 17511:2003 |
In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological tracebility of values assigned to calibrators and control materials (ISO 17511:2003) |
$105.00 |
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EN/ ISO 18153:2003 |
In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003) |
$105.00 |
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