ISO 11135-1-2007

医疗保健产品灭菌 环氧乙烷 第1部分:医疗器械灭菌工艺的设定、确认和常规控制的要求

Sterilization of health care products. Ethylene oxide. Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices first edition [superseded:Iso 11...

适用范围：This part of ISO 11135 specifies requirements for the development, validation and routine control of anethylene oxide sterilization process for medical devices.NOTE 1 Although the scope of this part of...

发布日期：2007-04-27  实施日期：2007-05-01

DIN EN ISO 11979-3-2006

眼科植入物 人工晶体 第3部分:机械特性与测试方法

Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods (ISO 11979-3:2006)

适用范围：The project specifies requirements and test methods for certain mechanical properties of intraocular lenses (IOLs). It is applicable to all types of IOLs intended for implantation in the anterior segme...

实施日期：2006-07-01

EN ISO 14607-2009

Non-active surgical implants. Mammary implants. Particular requirements

实施日期：2009-05-01

DIN EN 1641-2010

Dentistry - Medical devices for dentistry - Materials

实施日期：2010-02-01

BS EN ISO 22413-2013

药物制剂的转换装置 试验方法和要求

Transfer sets for pharmaceutical preparations. Requirements and test methods

发布日期：2013-04-30  实施日期：2013-04-30

NF S98-101-1-2007

Sterilization of health care products - Ethylene oxide - Part 1 : requirements for development, validation and routine control of a sterilization process for medical devices.

NF T72-502-1997

Chemical disinfectants and antiseptics. Hygienic handrub. Test method and requirements (phase2/step 2).

NF S98-107-2-2004

"Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 2 : requirements for aseptically processed medical devices".

BS EN 13726-6-2003

主要伤口敷料试验方法 第6部分:气味控制

Nichtaktive Medizinprodukte. Pruefverfahren fuer primaere Verbandstoffe (Wundauflagen). Geruchsbindung Non-active medical devices Test methods for primary wound dressings Part 6:Odour control Dispositi...

适用范围：This European Standard describes a test method for the evaluation of the resistance of primary wound dressings to penetration by odour.

实施日期：2003-05-13

BS EN ISO 22612-2005

传染介质防护服.防干微生物渗入的试验方法

Schutzkleidung gegen infektioese Agenzien. Pruefverfahren zur Bestaendigkeit gegen mikrobielle Penetration im trockenen Zustand Clothing for protection against infectious agents Test method for resista...

适用范围：This test method provides a means for assessing the resistance to penetration through barrier materials ofbacteria-carrying particles.NOTE Due to its complexity, this EN ISO 22612 cannot be considered ...

实施日期：2005-03-24

DIN EN ISO 23640-2013

In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)

发布日期：2013-09-01  实施日期：2013-09-01

DIN EN ISO 14607-2009

无源外科植入物 乳房植入物 特殊要求

Non-active surgical implants - Mammary implants - Particular requirements

适用范围：This International Standard specifies particular requirements for mammary implants for clinical practice.With regard to safety, this International Standard specifies requirements for intended performan...

实施日期：2009-08-01

ISO 11137-2-2013

保健产品的灭菌 辐射 第2部分:确定杀菌剂量

Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose

实施日期：2013-06-01

DIN EN 1041-2008

Information supplied by the manufacturer of medical devices

实施日期：2008-11-01

DIN EN ISO 22442-2-2008

Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling

实施日期：2008-03-01

DIN EN 1640-2010

Dentistry - Medical devices for dentistry - Equipment

实施日期：2010-02-01

ISO 22442-3-2007

利用动物组织及其衍生物的医疗设备 第3部分:病毒和传染性海绵状脑病(TSE)试剂的消灭和/或失效的确认

Medical devices utilizing animal tissues and their derivatives. Part 3:Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (tse) agents first editio...

适用范围：This part of ISO 22442 specifies requirements for the validation of the elimination and/or inactivation of virusesand TSE agents during the manufacture of medical devices (excluding in vitro diagnostic...

实施日期：2007-12-15

DIN ISO 11418-1-2005

药剂容器及附件 第1部分:玻璃滴瓶

Containers and accessories for pharmaceutical preparations - Part 1: Drop dispensing glass bottles (ISO 11418-1:2005)

适用范围：This part of ISO 11418 specifies the design, dimensions, material and requirements of drop-dispensing glass bottles. Drop-dispensing glass bottles are applicable to primary packs used in direct contact...

实施日期：2005-08-01

EN ISO 7376-2009

Anaesthetic and respiratory equipment. Laryngoscopes for tracheal intubation

实施日期：2009-08-01

EN 15908-2010

Anaesthetic and respiratory equipment. Non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases

实施日期：2010-10-01