C30 医疗器械综合 标准查询与下载
共找到 1389 条与 医疗器械综合 相关的标准，共 93 页
Sterilization of health care products. Biological indicators. Biological indicators for low-temperature steam and formaldehyde sterilization processes
- ICS
- 11.080.01
- CCS
- C30
- 发布
- 2017-04-30
- 实施
- 2017-04-30
Sterilization of health care products. Biological indicators. Biological indicators for moist heat sterilization processes
- ICS
- 11.080.01
- CCS
- C30
- 发布
- 2017-04-30
- 实施
- 2017-04-30
Sterilization of health care products. Biological indicators. Biological indicators for dry heat sterilization processes
- ICS
- 11.080.01
- CCS
- C30
- 发布
- 2017-04-30
- 实施
- 2017-04-30
Sterilization of health care products. Biological indicators. General requirements
- ICS
- 11.080.01;11.080.20
- CCS
- C30
- 发布
- 2017-04-30
- 实施
- 2017-04-30
Sterilization of health care products. Biological indicators. Biological indicators for ethylene oxide sterilization processes
- ICS
- 11.080.01
- CCS
- C30
- 发布
- 2017-04-30
- 实施
- 2017-04-30
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
- ICS
- 11.100.20
- CCS
- C30
- 发布
- 2017-04
- 实施
Rail systems for supporting medical equipment (ISO 19054:2005 + Amd1:2016); German version EN ISO 19054:2006 + A1:2016
- ICS
- 11.040.99
- CCS
- C30
- 发布
- 2017-04
- 实施
Methods for evaluating the immunogenicity of medical devices Part 4: In vivo test of phagocytosis of chicken red blood cells by mouse peritoneal macrophages
- ICS
- 11.040.01
- CCS
- C30
- 发布
- 2017-03-28
- 实施
- 2018-04-01
Biological evaluation of medical devices for human in vitro assisted reproductive technology and human sperm survival test
- ICS
- 11.040.30
- CCS
- C30
- 发布
- 2017-03-28
- 实施
- 2018-04-01
Medical device biological evaluation nanomaterials hemolysis test
- ICS
- 11.040.30
- CCS
- C30
- 发布
- 2017-03-28
- 实施
- 2018-04-01
Specific requirements for silicone gel-filled breast implants Performance requirements for silicone gel fillers Part 1: Limit requirements for volatile substances
- ICS
- 11.040.30
- CCS
- C30
- 发布
- 2017-03-28
- 实施
- 2018-04-01
Test method for in vitro pulsating flow performance of cardiovascular implant pulmonary artery valved conduits
- ICS
- 11.040.30
- CCS
- C30
- 发布
- 2017-03-28
- 实施
- 2018-04-01
Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
- ICS
- 11.080.01
- CCS
- C30
- 发布
- 2017-03-01
- 实施
Medical device reproductive and developmental toxicity testing Part 4: Two generations of reproductive toxicity testing
- ICS
- 11.040.01
- CCS
- C30
- 发布
- 2017-02-28
- 实施
- 2018-01-01
This European Standard specifies test methods and values for paper, used in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) used as sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2 this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this European Standard. The materials specified in this part of EN 868 are intended for single use only.
Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods
- ICS
- 11.080.30
- CCS
- C30
- 发布
- 2017-02
- 实施
This European Standard specifies test methods and values for paper used in the manufacture of preformed sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2 this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this European Standard. Paper specified in this European Standard is intended for use in part or complete manufacture of pouches and form and fill packs and lidding material for trays. NOTE 1 The paper specified in this part of the EN 868 series is suitable for the manufacture of sterile barrier systems to be used in ethylene oxide, irradiation or low temperature steam formaldehyde sterilization processes and to produce coated paper according to EN 868-7. NOTE 2 Paper according to EN 868-3 can also be used for these sterilization processes. The materials specified in this part of EN 868 are intended for single use only.
Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
- ICS
- 11.080.30
- CCS
- C30
- 发布
- 2017-02
- 实施
This European Standard specifies test methods and values for materials for sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2 this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this European Standard. While materials specified in 4.2.2.1 to 4.2.2.3 of this part of EN 868 are intended for single use, the materials specified in 4.2.2.4 are intended for reuse.
Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
- ICS
- 11.080.30
- CCS
- C30
- 发布
- 2017-02
- 实施
This European Standard specifies test methods and values for paper bags manufactured from paper specified in EN 868-3, used as sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2 this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this European Standard. The materials specified in this part of EN 868 are intended for single use only.
Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
- ICS
- 11.080.30
- CCS
- C30
- 发布
- 2017-02
- 实施
Surgical instruments - Materials - Part 1: Metals (ISO 7153-1:2016); German version EN ISO 7153-1:2016
- ICS
- 11.040.30;77.140.20
- CCS
- C30
- 发布
- 2017-02
- 实施
This European Standard specifies test methods and values for sealable adhesive coated paper manufactured from paper complying with EN 868-6, used as sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. The materials specified in this part are intended to be used for ethylene oxide or irradiation sterilization. Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2 this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this European Standard. The materials specified in this part of EN 868 are intended for single use only.
Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
- ICS
- 11.080.30
- CCS
- C30
- 发布
- 2017-02
- 实施
