11.040.20 输血、输液和注射设备 标准查询与下载
共找到 1427 条与 输血、输液和注射设备 相关的标准，共 96 页
This International Standard specifies general requirements and test methods for aluminium caps for injection vials, and for infusion and transfusion bottles.
Aluminium caps for transfusion, infusion and injection bottles - General requirements and test methods
- ICS
- 11.040.20
- CCS
- 发布
- 2013-04-01
- 实施
1.1 This part of ISO 8871 defines procedures for classifying elastomeric parts for primary packs and medical devices used in direct contact with preparations for parenteral use, including both aqueous preparations and dry preparations which have to be dissolved before use. It specifies a series of comparative test methods for chemical evaluation by the determination of extractables in aqueous autoclavates (see Clause 4) and describes the various fields of application for elastomeric parts. Dimensions and functional characteristics are specified in the relevant International Standards. Required properties as specified in this part of ISO 8871 are regarded as minimum requirements. 1.2 This part of ISO 8871 is applicable for the categories of elastomeric parts given in Clause 3; specific requirements, however, are laid down in the relevant International Standards dealing with the items or devices listed in Clause 3. Elastomeric parts for empty syringes for single use are excluded from the scope of this part of ISO 8871 as they are not in contact with the injected preparation for a significant length of time. 1.3 Compatibility studies with the intended preparation have to be performed before the approval for final use can be given; however, this part of ISO 8871 does not specify procedures for carrying out compatibility studies. studies.
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 1: Extractables in aqueous autoclavates
- ICS
- 11.040.20
- CCS
- 发布
- 2013-04-01
- 实施
This part of ISO 8362 specifies caps made of aluminium-plastics combinations for injection vials as specified in ISO 8362-1 and ISO 8362-4.
Injection containers and accessories - Part 6: Caps made of aluminium-plastics combinations for injection vials
- ICS
- 11.040.20
- CCS
- 发布
- 2013-04-01
- 实施
This part of ISO 8362 specifies the form, dimensions and capacities of glass vials for injectable preparations. It also specifies the material from which such containers shall be made and the performance requirements of those containers. This part of ISO 8362 applies to colourless or amber glass containers made from borosilicate or soda-lime glass, made from glass tubing, whether internally surface-treated or not, and intended to be used in the packaging, storage or transportation of products intended for injection.
Injection containers and accessories - Part 1: Injection vials made of glass tubing
- ICS
- 11.040.20
- CCS
- 发布
- 2013-04-01
- 实施
Infusion equipment for medical use - Part 12: Check valves (ISO 8536-12:2007 + Amd. 1:2012)
- ICS
- 11.040.20
- CCS
- C31
- 发布
- 2013-04
- 实施
1 Scope This part of ISO 8536 specifies caps made of aluminium-plastics combinations intended for use on infusion glass bottles which are in accordance with ISO 8536-1.
Infusion equipment for medical use - Caps made of aluminium-plastics combinations for infusion bottles
- ICS
- 11.040.20
- CCS
- 发布
- 2013-03-31
- 实施
- 2013-03-31
Infusion equipment for medical use. Caps made of aluminium-plastics combinations for infusion bottles
- ICS
- 11.040.20
- CCS
- C31
- 发布
- 2013-03-31
- 实施
- 2013-03-31
Infusion equipment for medical use. Infusion sets for single use, gravity feed
- ICS
- 11.040.20
- CCS
- C31
- 发布
- 2013-03-31
- 实施
- 2013-03-31
Infusion equipment for medical use. Infusion sets for single use, gravity feed
- ICS
- 11.040.20
- CCS
- C31
- 发布
- 2013-03-31
- 实施
- 2013-03-31
This part of ISO 8536 specifies requirements for single use, gravity feed infusion sets for medical use in order to ensure their compatibility with containers for infusion solutions and intravenous equipment.Secondary aims of this part of ISO 8536 are to
Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
- ICS
- 11.040.20
- CCS
- 发布
- 2013-03-21
- 实施
- 2013-03-21
ISO 8536-5:2004 specifies requirements for types of single-use, gravity feed burette infusion sets of 50 ml, 100 ml and 150 ml nominal capacity for medical use in order to ensure compatibility of use with containers for infusion solutions and intravenous
Infusion equipment for medical use - Part 5: Burette infusion sets for single use, gravity feed
- ICS
- 11.040.20
- CCS
- 发布
- 2013-03-21
- 实施
- 2013-03-21
Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed; Amendment 1
- ICS
- 11.040.20
- CCS
- C37
- 发布
- 2013-03
- 实施
Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2010/Amd 1:2013)
- ICS
- 11.040.20
- CCS
- 发布
- 2013-03
- 实施
Infusion equipment for medical use. Burette infusion sets for single use, gravity feed
- ICS
- 11.040.20
- CCS
- C31
- 发布
- 2013-02-28
- 实施
- 2013-02-28
This part of ISO 8536 gives users information on sterilized infusion sets for single use with pressure infusion equipment up to a maximum of 200 kPa (2 bar).
Infusion equipment for medical usePart 8:Infusion equipment for use with pressure infusion apparatus
- ICS
- 11.040.20
- CCS
- 发布
- 2013-02-08
- 实施
This part of ISO 8536 applies to sterilized fluid lines for single use for use with pressure infusion equipment up to a maximum of 200 kPa (2 bar). The following items are covered by this part of ISO 8536: a) syringe pump lines (SPL); b) connecting lines (CL); c) lines with integrated injection cannula (LIC).
Infusion equipment for medical usePart 9:Fluid lines for use with pressure infusion equipment
- ICS
- 11.040.20
- CCS
- 发布
- 2013-02-08
- 实施
Dieser Teil von ISO 8536 legt Anforderungen an zur einmaligen Verwendung bestimmte medizinische Infusionsgerate fur Schwerkraftinfusionen fest, um sicherzustellen, dass sie zur Verwendung mit Behaltern fur Infusionslosungen und Geraten zur intravenosen Punktion geeignet sind. Sekundares Ziel dieses Teils von ISO 8536 ist eine Anleitung zu Festlegungen bezuglich Qualitat und Leistungsfahigkeit der Werkstoffe, die fur Infusionsgerate verwendet werden. Auserdem werden Benennungen fur die Einzelteile von Infusionsgeraten angegeben. In einigen Landern sind das nationale Arzneibuch oder andere nationale Bestimmungen rechtlich bindend und haben Vorrang vor diesem Teil von ISO 8536.
Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
- ICS
- 11.040.20
- CCS
- C31
- 发布
- 2013-02-01
- 实施
- 2013-03-01
This part of ISO 8536 specifies requirements for types of single-use, gravity feed burette infusion sets of 50 ml, 100 ml and 150 ml nominal capacity for medical use in order to ensure compatibility of use with containers for infusion solutions and intravenous equipment.This part of ISO 8536 also provides guidance on specifications relating to the quality and performance of materials used in infusion sets.NOTE In some countries, national pharmacopoeia or other national regulations are legally binding and take precedence over this part of ISO 8536.
Infusion equipment for medical use - Part 5: Burette infusion sets for single use, gravity feed
- ICS
- 11.040.20
- CCS
- 发布
- 2013-02-01
- 实施
Infusion equipment for medical use - Part 12: Check valves; Amendment 1
- ICS
- 11.040.20
- CCS
- C31
- 发布
- 2012-10
- 实施
This technical report describes the technical requirements for use of equipment in HAEMODIALYSIS, HAEMOFILTRATION and HAEMODIAFILTRATION. These principles should be complied with to ensure safe, permissible and proper application.The physician is responsi
Guideline for safe operation of medical equipment used for haemodialysis treatments
- ICS
- 11.040.20
- CCS
- 发布
- 2012-09-28
- 实施
- 2012-09-28
