C08 标志、包装、运输、贮存 标准查询与下载

DIN 96042:2006 医疗器械. 包装. 技术规范

Medical instruments - Packaging - Technical specification

SANS 1384:2006 注射液用塑料容器

Covers the requirements for plastics containers (rigid, semi-rigid and collapsible) for aqueous solutions for intravenous infusion. It does not cover containers for blood and its components.

Plastics containers for parenteral solutions

DIN EN 14375 Corrigendum 1:2006 医药产品用防止儿童打开的包装. 试验和要求. 英文版本DIN EN 14375: 2004-02勘误表1

Child-resistant non-reclosable packaging for pharmaceutical products - Requirements and testing Corrigendum 1 to English version of DIN EN 14375:2004-02

ASTM F2559-06 书写可灭菌可剥离袋规范的标准指南

Medical device peel pouches are universally used by the industry and produced by a myriad of suppliers. They may be constructed of many different materials including films, foils, paper, nonwovens such as Tyvek, and combinations thereof. However, even with the diversity of materials, there are still basic requirements that all pouches should exhibit. Above all, the pouches must contain and protect the device while maintaining sterility during all physical handling. Pouch requirements may be divided into two categories, initial pouch and material qualification, and routine production and receipt requirements to ensure the purchaser receives exactly what is ordered. While all requirements should be included in the written specification, initial qualification tests may only be needed prior to the first order. Routine production and receipt requirements should be adhered to on every order. Initial qualification requirements are indicated within each clause, where applicable. This guide provides an understanding of the requirements needed for the manufacture, purchase, and acceptance of a preformed peelable pouch. Appropriate test methods for compliance are also cited. Note 18212;All test methods for a particular requirement may not be cited due to specific or unique circumstances. For additional guidance on applicable methods, refer to Guide F 2097. The specification and its requirements should be mutually agreed to by the supplier and purchaser of pouches. This helps ensure that pouches will comply to specified requirements.1.1 This guide defines the requirements and considerations for flexible peel pouches with one open, unsealed end that are intended to be sterilized containing medical devices. These are also known as preformed sterile barrier systems.1.2 Pouch styles are categorized as chevron, header, and corner peel. These pouches are typically manufactured by heat sealing, or in some cases, by cohesive cold sealing. The sealing bond is intended to be peeled open to aseptically dispense the contents.1.3 Pouch materials may be either porous, nonporous, or any combination of the two.1.4 This guide addresses some critical printing requirements on the pouch.1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

Standard Guide for Writing a Specification for Sterilizable Peel Pouches

ANSI/AAMI/ISO 11607-1:2006 最后灭菌的医疗器械的包装.第1部分:原材料,消毒阻挡系统和包装的要求

Specifies the requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use.

Packaging for teminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging

ANSI/AAMI/ISO 11607-2:2006 最后灭菌的医疗器械的包装.第2部分:组成,密封和装配过程的确认和要求

Specifies the requirements for development and validation of processes for packaging medical devices that are terminally sterilized and maintain sterility to the point of use. These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.

Packaging for terminally sterilized medical devices - Part 2: Validation and requirements for forming, sealing and assembly processes

DIN ISO 11418-2:2005 药剂制备容器及附件.第2部分:糖浆用螺口玻璃瓶

Containers and accessories for pharmaceutical preparations - Part 2: Screw-neck glass bottles for syrups (ISO 11418-2:2005); text in German and English

DIN ISO 11418-3:2005 药剂制备容器及附件.第3部分:固体和液体药剂用螺口玻璃瓶

This part of ISO 11418 specifies the design, dimensions, material and requirements of scew-neck glass bottles (veral) for pharmaceutical preparations in solid and liquid dosage forms. Screw-neck glass bottles are applicable to primary packs used in direct contact with a drug. This part of ISO 11418 applies to screw-neck glass bottles (veral) used in pharmacy. Together with the corresponding closure systems, they serve for packaging of pharmaceutical preparations in solid and liquid dosage forms which are not intended for parenteral use.#,,#

Containers and accessories for pharmaceutical preparations - Part 3: Screw-neck glass bottles (veral) for solid and liquid dosage forms (ISO 11418-3:2005); text in German and English

DIN ISO 11418-1:2005 药剂制备容器及附件.第1部分:玻璃点滴瓶

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 with a drug.this part of ISO 11418 applies to drop-dispensing bottles used in pharmacy. Together with the corresponding closure systems, they serve for packaging of pharmaceutical preparations which are not intended for parenteral use.#,,#

Containers and accessories for pharmaceutical preparations - Part 1: Drop-dispensing glass bottles (ISO 11418-1:2005); text in German and English

DIN ISO 11418-4:2005 药剂制备容器及附件.第4部分:片剂玻璃瓶

Containers and accessories for pharmaceutical preparations - Part 4: Tablet glass bottles (ISO 11418-4:2005); text in German and English

NF X30-505:2004 医疗保健废弃物的包装.保健废弃物.具有传染风险的保健废弃物用塑料桶和金属制液体容器

Packaging for medical care waste - Health care waste - Plastic barrel and jerrycans for infections risk health care waste.

YBB 0031-2003 硼硅玻璃模制注射剂瓶

Pengguiboli Mozhi Zhusheji Ping Injection vials made of moulded borosilicate glass

YBB 0036-2003 钠钙玻璃管制药瓶

Nagaiboli Guanzhi Yaoping Medicinal vials made of soda lime glass tubing

YBB 0027-2003 低硼硅玻璃药用管

Dipengguiboli Yaoyongguan Pharmaceutical tube made of low borosilicate glass

YBB 0028-2003 钠钙玻璃药用管

Nagaiboli Yaoyongguan Pharmaceutical tube made of soda lime glass

YBB 0030-2003 低硼硅玻璃模制药瓶

Dipengguiboli Mozhi Yao Ping

YBB 0032-2003 低硼硅玻璃模制注射剂瓶

Dipengguiboli Mozhi Zhusheji Ping Injection vials made of moulded low borosilicate glass

YBB 0033-2003 钠钙玻璃管制注射剂瓶

Nagaiboli Guanzhizhusheji Ping

YBB 0035-2003 低硼硅玻璃管制药瓶

Dipengguiboli Guanzhi Yaoping Medicine vials made of low borosilicate glass tubing

YBB 0034-2003 药用玻璃成份分类及其试验方法

Yaoyongbolichengfen Fenlei Jiqi Shiyanfangfa Glass composition & test method for pharmaceutical packaging container