C92 制药加工机械与设备 标准查询与下载

YBB 0019-2004 双向拉伸聚丙烯/真空镀铝流延聚丙烯药品包装用复合膜、袋

Laminated Films and Pouches (BOPP/VMCPP) for Pharmaceutical Packaging

YBB 0018-2004 铝/聚乙烯冷成型固体药用复合硬片

AL/PE cold-formed foil for Solid Pharmaceutical Packaging

YBB 0017-2004 口服固体药用低密度聚乙烯防潮组合瓶盖

LDPE Bottle Caps with Drying agent for Oral Solid Preparation

YBB 0005-2004 硼硅玻璃模制药瓶

Medicinal bottles made of moulded borosilicate glass

YBB 0004-2004 硼硅玻璃管制药瓶

Medicinal vials made of borosilicate glass tubing

YBB 0003-2004 纳钙玻璃管制口服液体瓶

Oral liquid bottles made of soda lime glass tubing

YBB 0001-2004 低硼硅玻璃输液瓶

Infusion bottles made of low borosilicate glass

DIN EN ISO 8871-2:2004 非肠道及制药设备用弹性件.第2部分:识别和表征

The project specifies evaluation procedures applicable to elastomeric parts used for drug containers and medical devices in order to guarantee the product identify between the samples evaluated in the (suitability test) acceptance process and the current supplies.

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization (ISO 8871-2:2003); German version EN ISO 8871-2:2004, text in German and English

DIN EN ISO 8871-1:2004 非肠道及制药设备用弹性件.第1部分:水蒸汽中的提取物

The project defines procedures for classifying elastomeric parts for primary packs and medical devices used in direct contact with aqueous preparations for parenteral use including dry preparations which have be dissolved before use.

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

BS EN ISO 8871-2:2004 非肠道及制药设备用弹性件.识别和特性

This part of ISO 8871 specifies evaluation procedures applicable to elastomeric parts used for drug containers and medical devices in order to guarantee the product identity between the samples evaluated in the (suitability test) acceptance process and the current supplies. The physical and chemical test procedures specified in this part of ISO 8871 permit the determination of the typical characteristics of rubber materials, and may serve as a basis for agreements between manufacturer and user regarding the product consistency in subsequent supplies. An appropriate set of tests is selected, depending upon the type of rubber and its application. This part of ISO 8871 does not specify other requirements for rubber materials. These are laid down in the relevant product standards.

Elastomeric parts for parenterals and for devices for pharmaceutical use - Identification and characterization

BS EN ISO 8871-1:2004 非肠道及制药设备用弹性件.水蒸压器中的萃取物

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. 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. 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.

Elastomeric parts for parenterals and for devices for pharmaceutical use - Extractables in aqueous autoclavates

DIN EN ISO 8871-3:2004 非肠道及制药设备用弹性件.第3部分:释放粒子计数的测定

Elastomeric parts may be superficially contaminated with particles visible to the naked eye. Such particles may be transferred to pharmaceutical preparations in contact with the elastomeric parts, and detoriate the quality of such preparations. The method serves to evaluate contamination of this kind by collecting and counting the particles, detached from the elastomeric part by rinsing.

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

BS EN ISO 8871-3:2004 非肠道及制药设备用弹性件.释放粒子计数的测定

Elastomeric closures may be superficially contaminated with visible and subvisible particles, and fragments can also be produced when the closure is pierced by a needle. Such particles may be transferred to pharmaceutical preparations in contact with the elastomeric parts and affect the quality of such preparations. This part of ISO 8871 specifies methods for the determination of the number of visible and subvisible particles, respectively, detached from elastomeric parts by rinsing. It does not specify particle contamination limits. These will have to be agreed upon between manufacturer and user.

Elastomeric parts for parenterals and for devices for pharmaceuticals use - Determination of released-particle count

JB 20003.5-2004 滴眼剂联动线.贴标机

本标准规定了滴眼剂贴标机的标记、要求、试验方法、检验规则和标志、使用说明书、包装和贮存。

Production line for eyedrops - Labelling machine

JB 20003.4-2004 滴眼剂联动线.灌装压塞旋盖机

本标准规定了滴眼剂灌装压塞旋盖机的型号和标记、要求、试验方法、检验规则和标志、使用说明书、包装和贮存。

Production line for eyedrops - Filling & closing machine

JB 20003.3-2004 滴眼剂联动线.隧道烘干机

本标准规定了滴眼剂隧道烘干机的标记、要求、试验方法和标志、使用说明书、包装和贮存。

Production line for eyedrops - Drying tunnel

JB 20003.2-2004 滴眼剂联动线.清洗机

本标准规定了滴眼剂清洗机的型号和标记、要求、试验方法和检验规则和标志、使用说明书、包装和贮存。

Production line for eyedrops - Cleaning machine

JB 20003.1-2004 滴眼剂联动线

本标准规定了滴眼剂联动线的分类和标记、要求、试验方法和检验规则。

Production line for eyedrops

JB 20002.5-2004 安瓿印字机

本标准规定了安瓿印字机的分类和标记、要求、试验方法、检验规则和标志、使用说明书、包装、运输和贮存。

Ampoule printing machine

JB 20002.4-2004 安瓿灌装封口机

本标准规定了安瓿灌装封口机的分类和标记、要求、试验方法、检验规则和标志、使用说明书、包装、运输、贮存。

Ampoule filling and sealing machine