C36 其他专科器械 标准查询与下载
共找到 798 条与 其他专科器械 相关的标准，共 54 页
Medical instruments - Part 1: Dissection forceps, straight
- ICS
- 11.040.30
- CCS
- C36
- 发布
- 2006-12
- 实施
This document is a product specification, giving performance requirements for emergency safety body showers connected to the water supply. It is applicable to plumbed-in body showers only, located in laboratory facilities. It is not applicable to emergency safety showers used on industrial sites or in other such areas. Requirements are given in respect of the performance, installation, adjustment and marking of the showers as well as installation, operation and maintenance instructions to be given by the manufacturer.
Emergency safety showers - Plumbed-in body showers for laboratories
- ICS
- 11.160;71.040.10
- CCS
- C36
- 发布
- 2006-10-31
- 实施
- 2006-10-31
이 규격은 의료 업무시 사용되는 내시경 및 내시경 부속품의 용어 정의 및 요구 사항에 대
Optics and optical instruments-Medical endoscopes and endoscopic accessories-Part 1:General requirements
- ICS
- 11.040.50
- CCS
- C36
- 发布
- 2006-06-09
- 实施
- 2006-06-09
Medical electrical equipment ?Part 2-50: Particular requirements for the safety of infant phototherapy equipment First Edition
Medical electrical equipment ?Part 2-50: Particular requirements for the safety of infant phototherapy equipment First Edition
- ICS
- CCS
- C36
- 发布
- 2006-01-01
- 实施
Les normes de l’Association canadienne de normalisation (CSA) sont élaborées selon un processus consensuel approuvé par le Conseil canadien des normes. Ce processus rassemble des volontaires représentant différents intérêts et points de vue dans le but d
Electromedical devices - Part 2-27: Special safety requirements - including essential performance, electrocardiography monitoring devices second edition
- ICS
- CCS
- C36
- 发布
- 2006
- 实施
1.1 These test methods cover the establishment of performance requirements for the utilization of a single-use, enteral feeding device with a retention balloon, used by medical professionals for providing a means of nutrition and/or administration of medication to patients by means of natural orifice (nasal, oral, transluminal) and or a surgically created stoma. The product is manufactured in various sizes and materials such as silicone, urethane, and various polymers (as well as combinations of these) and is provided nonsterile for sterilization and sterile for single use only. Rationale for these test methods can be found in Appendix X1.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 to determine the applicability of regulatory limitations prior to use.
Standard Test Methods for Enteral Feeding Devices with a Retention Balloon
- ICS
- 11.040.99 (Other medical equipment)
- CCS
- C36
- 发布
- 2006
- 实施
This guide is intended to provide the foundation of standards for clinical assessment, clinical performance, and preclinical assessment of substitutes for skin grafts. This guide is intended to aid accurate claims and labeling for the clinical utilities of substitutes for skin grafts in regulatory reviews. In this guide, “replacement” and “substitute” have different meanings, although they can be used synonymously in ordinary English. “Replacement” is used only as an adjective in the context of “skin replacement surgery,” which is defined in . “Substitute” is used only as a noun in the context of “skin substitute,” which is defined in 2.1.7.11.1.1 This guide defines terminology and provides a system of classification for products that can be substituted for human or animal skin grafts (or grafts of the dermal or epidermal component tissues of skin) in medical and surgical therapies. This guide is intended to include (or be expandable to) possible future tissue engineered skin technology that could provide novel or superior therapeutic properties to those of natural skin grafts.1.2 As much as possible, terminology is based on medical dictionary definitions.1.3 Substitutes for skin grafts are classified by clinical utility only; the classification is independent of the technology used to make a skin substitute, its components, or whether the sources of components include human or animal tissue or other biological or non-biological materials.1.4 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 requirements prior to use.
Standard Guide for Classification of Therapeutic Skin Substitutes
- ICS
- 11.120.99 (Other standards related to pharmaceutic
- CCS
- C36
- 发布
- 2006
- 实施
This part of ISO 8871 specifies requirements and test methods for functional parameters of elastomeric closures used in combination with vials and when pierced by an injection needle. NOTE Functional testing with spikes is specified in ISO 8536-2 and in ISO 8536-6.
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing
- ICS
- 11.040.20
- CCS
- C36
- 发布
- 2005-08
- 实施
This is Amendment 1 to ISO 8871-2-2003 (Elastomeric parts for parenterals and for devices for pharmaceutical use Part 2: Identification and characterization)
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization; Amendment 1
- ICS
- 11.040.20
- CCS
- C36
- 发布
- 2005-07
- 实施
This part of ISO 8600 defines terms and gives requirements for endoscopes and endotherapy devices used in the practice of medicine.
Optics and photonics - Medical endoscopes and endotherapy devices - Part 1: General requirements
- ICS
- 11.040.55
- CCS
- C36
- 发布
- 2005-05
- 实施
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2 : identification and characterization.
- ICS
- 11.040.20
- CCS
- C36
- 发布
- 2005-04-01
- 实施
- 2005-04-20
