Injection containers and accessories - Part 1: Injection vials made of glass tubing (ISO 8362-1:2009 + Amd 1:2015) (includes Amendment A1:2015)— 15 стр.
Injection containers for injectables and accessories - Part 3: Aluminium caps for injection vials (ISO 8362-3:2001); German version EN ISO 8362-3:2003; German and English texts— 18 стр.
Injection containers and accessories - Part 5: Freeze drying closures for injection vials (ISO 8362-5:2016); German version EN ISO 8362-5:2016— 18 стр.
Injection containers and accessories - Part 6: Caps made of aluminium-plastics combinations for injection vials (ISO 8362-6:2010); German version EN ISO 8362-6:2011— 11 стр.
Injection containers and accessories - Part 7: Injection caps made of aluminium-plastics combinations without overlapping plastics part (ISO 8362-7:2006); German version EN ISO 8362-7:2010— 12 стр.
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 1: Extractables in aqueous autoclavates (ISO 8871-1:2003); German version EN ISO 8871-1:2004, text in German and English— 32 стр.
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization (ISO 8871-2:2003 + Amd.1:2005); German version EN ISO 8871-2:2004 + A1:2014— 31 стр.
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 3: Determination of released-particle count (ISO 8871-3:2003); German version EN ISO 8871-3:2004, text german and english— 12 стр.
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 4: Biological requirements and test methods (ISO 8871-4:2006); German version EN ISO 8871-4:2006— 12 стр.
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO 8871-5:2005); German version EN ISO 8871-5:2014— 18 стр.
Small bore connectors for liquids and gases in healthcare applications - Part 7: Connectors with 6% (Luer) taper for intravascular or hypodermic applications (ISO/DIS 80369-7:2013); German version prEN ISO/IEC 80369-7:2013
Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods (ISO 80369-20:2015); German version EN ISO 80369-20:2015— 36 стр.
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization - Amendment 1 (ISO 8871-2:2003 + Amd 1:2005) (consolidated version)
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO/DIS 8871-5:2015); German and English version prEN ISO 8871-5:2015
Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (ISO 9626:2016); German version EN ISO 9626:2016— 35 стр.
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO/DIS 10993-16:2016); German and English version prEN ISO 10993-16:2016
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01); German version EN ISO 14971:2012— 112 стр.
Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO/DIS 15223-1:2015); German and English version prEN ISO 15223-1:2015
Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling (ISO 23908:2011)
Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO/DIS 80369-1:2015); German and English version prEN ISO 80369-1:2015
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO 8871-5:2016); German version EN ISO 8871-5:2016— 18 стр.
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO 8871-5:2005); German version EN ISO 8871-5:2014— 18 стр.
Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling (ISO 11040-4:2015); Text in German and English— 68 стр.
Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports (ISO 10555-6:2015); German and English version FprEN ISO 10555-6:2017— 27 стр.
Sterile hypodermic syringes for single use - Part 1: Syringes for manual use (ISO 7886-1:1993, including Technical Corrigendum 1:1995); German version EN ISO 7886-1:1996— 20 стр.
Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010); German version EN ISO 8638:2014— 24 стр.
Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8637-2:2018); German version EN ISO 8637-2:2018— 30 стр.
Sharps injury protection - Requirements and test methods - Part 1: Single-use sharps containers (ISO 23907-1:2019); German version EN ISO 23907-1:2019— 21 стр.
Sterile single-use intravascular introducers, dilators and guidewires (ISO 11070:2014 + Amd 1:2018); German version EN ISO 11070:2014 + A1:2018— 38 стр.
Sterile single-use intravascular introducers, dilators and guidewires (ISO 11070:2014 + Amd 1:2018); German version EN ISO 11070:2014 + A1:2018— 38 стр.
Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports (ISO 10555-6:2015); German version EN ISO 10555-6:2017— 27 стр.
Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2010 + Amd 1:2013); German version EN ISO 8536-4:2013 + A1:2013— 26 стр.
Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature (ISO 7886-4:2006); German version EN ISO 7886-4:2009— 24 стр.
Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose immunization (ISO 7886-3:2005); German version EN ISO 7886-3:2009— 21 стр.
Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven syringe pumps (ISO 7886-2:1996); German version EN ISO 7886-2:1997— 16 стр.
Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances; German version EN 13718-2:2015— 37 стр.
