C31 一般与显微外科器械 标准查询与下载



共找到 1323 条与 一般与显微外科器械 相关的标准,共 89

Pen systems - Part 2: Plunger stoppers for pen-injectors for medical use; Amendment 1

ICS
11.040.25
CCS
C31
发布
2015-08
实施

Dentistry - Dental amalgam

ICS
11.060.10
CCS
C31
发布
2015-07-03
实施
2015-07-03

Small-bore connectors for liquids and gases in healthcare applications. Common test methods

ICS
CCS
C31
发布
2015-06-30
实施
2015-06-30

Infusion equipment for medical use. Infusion filters for single use with pressure infusion equipment

ICS
11.040.20
CCS
C31
发布
2015-06-30
实施
2015-06-30

Infusion equipment for medical use. Fluid lines for single use with pressure infusion equipment

ICS
11.040.20
CCS
C31
发布
2015-06-30
实施
2015-06-30

Infusion equipment for medical use. Accessories for fluid lines for single use with pressure infusion equipment

ICS
11.040.20
CCS
C31
发布
2015-06-30
实施
2015-06-30

Infusion equipment for medical use. Infusion sets for single use with pressure infusion apparatus

ICS
11.040.20
CCS
C31
发布
2015-06-30
实施
2015-06-30

This part of ISO 8536 applies to sterilized infusion filters for single use used up to 200 kPa (2 bar) on fluid lines of pressure infusion equipment and infusion set as specified in ISO 8536-8. It does not include the effectiveness of filters for separation of particles or germs. In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this part of ISO 8536.

Infusion equipment for medical use - Part 11: Infusion filters for single use with pressure infusion equipment

ICS
11.040.20
CCS
C31
发布
2015-06
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); c) lines with integrated injection cannula (LIC). b) connecting lines (CL); In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this part of ISO 8536.

Infusion equipment for medical use - Part 9: Fluid lines for single use with pressure infusion equipment

ICS
11.040.20
CCS
C31
发布
2015-06
实施

This part of ISO 8536 gives users information on sterilized infusion sets for single use with pressure infusion apparatus up to a maximum of 200 kPa (2 bar). In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this part of ISO 8536.

Infusion equipment for medical use - Part 8: Infusion sets for single use with pressure infusion apparatus

ICS
11.040.20
CCS
C31
发布
2015-06
实施

Intravascular catheters. Sterile and single-use catheters. Subcutaneous implanted ports

ICS
11.040.25
CCS
C31
发布
2015-04-30
实施
2015-04-30

Prefilled syringes. Packaging systems for sterilized subassembled syringes ready for filling

ICS
11.040.25
CCS
C31
发布
2015-04-30
实施
2015-04-30

Prefilled syringes. Glass barrels for injectables and sterilized subassembled syringes ready for filling

ICS
11.040.25
CCS
C31
发布
2015-04-30
实施
2015-04-30

Medical electrical equipment -- Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems

ICS
11.180.15;17.140.50
CCS
C31
发布
2015-04-01
实施

This part of ISO 11040 specifies the packaging system that is used to deliver sterilized subassembled syringes ready for filling in tubs and nests. Downstream processes (processes after filling such as in house/outside transport, reprocessing) can result in specific requirements on the packaging system used to deliver sterilized subassembled syringes ready for filling. However, these requirements are not within the scope of this part of ISO 11040. NOTE 1 Glass barrels and sterilized subassembled syringes ready for filling, plungers, and plastic barrels for injectables are specified in ISO 11040-4, ISO 11040-5, and ISO 11040-6. NOTE 2

Prefilled syringes - Part 7: Packaging systems for sterilized subassembled syringes ready for filling

ICS
11.040.25
CCS
C31
发布
2015-04
实施

Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports

ICS
11.040.25
CCS
C31
发布
2015-04
实施

This part of ISO 11040 applies to — tubing-glass barrels (single-chamber design) for injection preparations, and — sterilized subassembled syringes ready for filling. It specifies materials, dimensions, quality, and performance requirements, as well as relevant test methods. This part of ISO 11040 also specifies those components that are part of the sterilized subassembled syringe ready for filling. Glass barrels and sterilized subassembled syringes ready for filling in accordance with this part of Components to complete the subassembled syringe, such as plunger and rod, are not specified in this part of ISO 11040. NOTE Attention is drawn to applicable national or regional regulations such as Ph. Eur., USP, or JP. Where relevant, specific references to Ph. Eur., USP, and JP have been given in specific clauses or subclauses of this part

Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling

ICS
11.040.25
CCS
C31
发布
2015-04
实施

Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2014); German version EN ISO 11608-1:2015

ICS
11.040.25
CCS
C31
发布
2015-04
实施

本标准规定了一次性使用输血器具用尼龙血液过滤网(以下简称过滤网)的要求。过滤网可安装于输(采)血器滴斗中或附件上,用于滤除血液或血制品中的凝血块、杂质和异物等。

Nylon blood filter nets for transfusion equipments for single use

ICS
11.040.20
CCS
C31
发布
2015-03-02
实施
2016-01-01

本标准规定了一次性使用动静脉穿刺器(以下简称穿刺器)的要求,以保证与所配套的血路和血液处理系统相适应。

A.V. fistula needle sets for single use

ICS
11.040.20
CCS
C31
发布
2015-03-02
实施
2016-01-01



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