技术性贸易措施公共服务平台

医疗类标准(三)

2019-07-23 21:39 

标准号

中文名称

英文名称

KS P ISO 7176-6-2011

轮椅第6部分:电动轮椅最大速度、加速度和减速度的测定

Wheelchairs-Part 6:Determination of maximum speed, acceleration and deceleration of   electric wheelchairs

KS P ISO 7176-7-2008

轮椅.第7部分:座位和轮子尺寸的测量

Wheelchairs — Part 7: Measurement of seating and   wheel dimensions

KS P ISO 7176-8-2018

轮椅.第8部分:静态、冲击和疲劳强度的要求和试验方法

Wheelchairs — Part 8: Requirements and test methods   for static, impact and fatigue strengths

KS P ISO 7176-9-2017

轮椅第9部分:电动轮椅气候试验

Wheelchairs-Part 9:Climatic tests for electric wheelchairs

KS P ISO 7197-2009

神经外科植入物.无菌的、一次性使用的脑积水分流管和组件

Neurosurgical implants-Sterile, single-use   hydrocephalus shunts and components

KS P ISO 7198-2007

心血管植入物.血管假体

Cardiovascular implants-Tubular vascular   prostheses

KS P ISO 7199-2012

心血管植入物和人工器官.血液-氧气交换机(氧合器)

Cardiovascular implants and artificial   organs-Blood-gas exchangers(oxygenators)

KS P ISO 7206-1-2012

外科植入物部分和全部髋关节假体第1部分:分类和尺寸命名

Implants for surgery-Partial and total hip   joint prostheses-Part 1:Classification   and designation of dimensions

KS P ISO 25539-1-2017

外科植入物部分和全部髋关节假体第10部分:模块化股骨头抗静载荷的测定

Implants for surgery-Partial and total   hip-joint prostheses-Part 10:Determination   of resistance to static load of modular femoral heads

KS P ISO 7206-2-2012

外科植入物部分和全部髋关节假体第2部分:金属、陶瓷和塑料制成的关节表面

Implants for surgery-Partial and total hip   joint prostheses-Part 2:Articulating   surfaces made of metallic, ceramic and plastics materials

KS P ISO 7206-4-2012

外科植入物部分和全部髋关节修复术第4部分:干股骨部件耐久性的测定

Implants for surgery-Partial and total hip   joint prostheses-Part 4:Determination   of endurance properties of stemmed femoral components

KS P ISO 7206-6-2007

外科植入物部分和全部髋关节假体第6部分:干股骨部件头颈部耐久性能的测定

Implants for surgery-Partial and total hip   joint prostheses-Part 6:Determination   of endurance properties of head and neck region of stemmed femoral components

KS P ISO 7207-1-2012

外科植入物部分和全部膝关节假体用部件第1部分:分类、定义和尺寸的命名

Implants for surgery-Components for partial   and total knee joint prostheses-Part 1:Classification, definitions and designation of dimensions

KS P ISO 7207-2-2012

外科植入物部分和全部膝关节假体部件第2部分:金属、陶瓷和塑料材料制关节表面

Implants for surgery-Components for partial   and total knee joint prostheses-Part 2:Articulating surfaces made of metal, ceramic and plastics   materials

KS P ISO 7396-1-2008

医用气体管道系统第1部分:医用压缩气体和真空管道系统

Medical gas pipeline systems-Part 1:Pipeline systems for compressed medical gases and vacuum

KS P ISO 7396-2-2008

医用气体管道系统第2部分:麻醉气体清除处理系统

Medical gas pipeline systems-Part 2:Anaesthetic gas scavenging disposal systems

KS P ISO 7405-2014

牙科学.用于牙科的医疗器械生物相容性临床前评价.牙科材料的试验方法

Dentistry — Evaluation of biocompatibility of   medical devices used in dentistry

KS P ISO 7491-2013

牙科材料颜色稳定性的测定

Dental materials-Determination of color   stability

KS P ISO 7492-2013

牙科用牙探针

Dental explorers

KS P ISO 7493-2012

牙科.医生凳

Dental operator's stool

KS P ISO 7494-1-2012

牙科学-牙科装置-第1部分:一般要求和试验方法

Dentistry-Dental units-Part 1:General requirements and test   methods

KS P ISO 7494-2-2004

牙科-牙科装置-第2部分:供水和供气

Dentistry-Dental units-Part 2:Water and air supply

KS P ISO 7551-2013

牙科吸收点

Dental absorbent points

KS P ISO 7711-1-2012

牙科旋转器械钻石器械第1部分:尺寸、要求、标志和包装

Dental rotary instruments-Diamond instruments-Part 1:Dimensions, requirements, marking   and packaging

KS P ISO 7711-2-2004

牙科旋转器械钻石器械第2部分:圆盘

Dental rotary instruments-Diamond instruments-Part 2:Discs

KS P ISO 7711-3-2004

牙科旋转器械钻石器械第3部分:磨粒尺寸、命名和色标

Dental rotary instruments-Diamond instruments-Part 3:Grit sizes, designation and color   code

KS P ISO 7741-2008

外科器械.剪刀和大剪刀.一般要求和试验方法

Instruments for surgery-Scissors and shears-General requirements and test methods

KS P ISO 7786-2004

牙科旋转器械.技工室用研磨器械

Dental rotary instruments-Laboratory abrasive   instruments

KS P ISO 7787-1-2004

牙科旋转器械切割器第1部分:实验室用钢切割器

Dental rotary instruments-Cutters-Part 1:Steel laboratory cutters

KS P ISO 7787-2-2013

牙科用旋转器械.切割刀具.第2部分:实验室用硬质合金刀具

Dental rotary instruments — Cutters–Part   2: Carbide laboratory cutters

KS P ISO 7787-3-2004

牙科旋转器械刀具第3部分:铣床用硬质合金实验室刀具

Dental rotary instruments-Cutters-Part 3:Carbide laboratory cutters for   milling machines

KS P ISO 7787-4-2012

牙科旋转器械刀具第4部分:实验室用小型硬质合金刀具

Dental rotary instruments-Cutters-Part 4:Miniature carbide laboratory   cutters

KS P ISO 7885-2017

灭菌一次性牙科直接注射针头

Dentistry-Sterile injection needles   for single use

KS P ISO 8185-2009

医用加湿器加湿系统的一般要求

Humidifiers for medical use -- General   requirements for humidification systems

KS P ISO 8282-2013

牙科设备.汞及合金混合器和调和器

Dental equipment-Mercury and alloy   mixers and dispensers

KS P ISO 8319-1-2010

骨科器械传动连接第1部分:内六角螺钉用键

Orthopaedic instruments-Drive connections-Part 1:Keys for use with screws with   hexagon socket heads

KS P ISO 8319-2-2010

骨科器械传动连接第2部分:单槽螺钉旋具、十字槽螺钉和十字槽螺钉

Orthopaedic instruments-Drive connections-Part 2:Screwdrivers for single slot head   screws, screws with cruciate slot and cross-recessed head screws

KS P ISO 8325-2012

牙科.旋转器械试验方法

Dentistry-Test methods for rotary   instruments

KS P ISO 8362-1-2017

注射容器及附件第1部分:玻璃管注射小瓶

Injection containers and accessories-Part 1:Injection vials made of glass tubing

KS P ISO 8362-2-2009

注射容器及附件第2部分:注射小瓶瓶盖

Injection containers and accessories-Part 2:Closures for injection vials

KS P ISO 8362-3-2009

注射容器及附件第3部分:注射小瓶铝盖

Injection containers and accessories-Part 3:Aluminium caps for injection vials

KS P ISO 8362-4-2014

注射容器及附件.第4部分:由模压玻璃制成的注射小瓶

Injection containers and accessories — Part 4:   Injection vials made of moulded glass

KS P ISO 8362-5-2009

注射容器及附件第5部分:注射小瓶冷冻干燥瓶盖

Injection containers and accessories-Part 5:Freeze drying closures for injection vials

KS P ISO 8362-6-2014

注射容器及附件.第6部分:注射小瓶用铝塑组合盖

Injection containers and accessories — Part 6: Caps   made of aluminium-plastics combinations for injection vials

KS P ISO 8362-7-2009

注射容器及附件第7部分:无重叠塑料部分的铝塑组合注射帽

Injection containers and accessories-Part 7:Injection caps made of aluminium-plastics combinations without   overlapping plastics part

KS P ISO 8536-1-2014

医用输液设备.第1部分:输液玻璃瓶

Infusion equipment for medical use — Part 1:   Infusion glass bottles

KS P ISO 25539-2-2009

医用输液设备第10部分:压力输液设备用输液管路附件

Infusion equipment for medical use-Part 10:Accessories for fluid lines for use with pressure infusion   equipment

KS P ISO 29783-2-2016

医用输液设备第11部分:压力输液设备用输液过滤器

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

KS P ISO 5832-10-2002

医用输液设备第12部分:止回阀

Infusion equipment for medical use-Part 12:Check valves

KS P ISO 5832-11-2007

医用输液设备第13部分:流体接触一次性使用刻度流量调节器

Infusion equipment for medical use ─ Part 13:   Graduated flow regulators for single use with fluid contact

KS P ISO 5832-12-2012

医用输液设备第14部分:无流体接触的输液和输液设备用夹具和流量调节器

Infusion equipment for medical use ─ Part 14:   Clamps and flow regulators for transfusion and infusion equipment without   fluid contact

KS P ISO 8536-2-2014

医用输液设备.第2部分:输液瓶瓶塞

Infusion equipment for medical use — Part 2:   Closures for infusion bottles

KS P ISO 8536-3-2009

医用输液设备第3部分:输液瓶铝盖

Infusion equipment for medical use-Part 3:Aluminium caps for infusion bottles

KS P ISO 8536-4-2014

医用输液设备.第4部分:一次性使用重力式输液器

Infusion equipment for medical use — Part 4:   Infusion sets for single use, gravity feed

KS P ISO 8536-5-2009

医用输液设备第5部分:一次性使用滴定管重力式输液器

Infusion equipment for medical use-Part 5:Burette infusion sets for single use, gravity feed

KS P ISO 8536-6-2009

医用输液设备第6部分:输液瓶冻干瓶塞

Infusion equipment for medical use-Part 6:Freeze drying closures for infusion bottles

KS P ISO 8536-7-2009

医用输液设备第7部分:输液瓶用铝塑组合盖

Infusion equipment for medical use-Part 7:Caps made of aluminium-plastics combinations for infusion bottles

KS P ISO 8536-8-2017

医用输液设备第8部分:带压力输液器的输液设备

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

KS P ISO 8536-9-2017

医用输液设备第9部分:带压力输液设备的输液管路

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

KS P ISO 8548-1-2008

假肢和矫形学肢体缺陷第1部分:先天性肢体缺陷的描述方法

Prosthetics and orthotics-Limb deficiencies-Part 1:Method of describing limb   deficiencies present at birth

KS P ISO 8548-2-2008

假肢和矫形学肢体缺陷第2部分:下肢截肢残端的描述方法

Prosthetics and orthotics-Limb deficiencies-Part 2:Method of describing lower limb   amputation stumps

KS P ISO 8548-3-2008

假肢和矫形学肢体缺陷第3部分:上肢截肢残端的描述方法

Prosthetics and orthotics-Limb deficiencies-Part 3:Method of describing upper limb amputation   stumps

KS P ISO 8548-4-2008

假肢和矫形学肢体缺陷第4部分:导致截肢的原因描述

Prosthetics and orthotics-Limb deficiencies-Part 4:Description of causal conditions   leading to amputation

KS P ISO 8549-1-2008

假肢和矫形学词汇第1部分:假肢和外矫形的一般术语

Prosthetics and orthotics-Vocabulary-Part 1:General terms for external limb   prostheses and external orthoses

KS P ISO 8549-2-2008

假肢和矫形学词汇第2部分:与假肢和假肢佩戴者有关的术语

Prosthetics and orthotics-Vocabulary-Part 2:Terms relating to external limb   prostheses and wearers of these prostheses

KS P ISO 8549-3-2008

假肢与矫形学词汇第3部分:外矫形术语

Prosthetics and orthotics-Vocabulary-Part 3:Terms relating to external orthoses

KS P ISO 8549-4-2016

修复术和矫形学.词汇.第4部分:与截肢有关的术语

Prosthetics and orthotics — Vocabulary — Part   4: Terms relating to limb amputation

KS P ISO 8596-2006

眼科光学.视觉敏锐度测验.标准验光字体及其演示

Ophthalmic optics-Visual acuity testing-Standard optotype and its presentation

KS P ISO 8597-2006

光学和光学仪器.视觉敏锐度测试.与验光字体相关的方法

Optics and optical instruments-Visual acuity testing-Method of correlating optotypes

KS P ISO 8612-2002

眼科仪器.张力计

Ophthalmic instruments-Tonometers

KS P ISO 8615-2008

外科植入物.用于成人股骨端的固定器

Implants for surgery-Fixation devices for   use in the ends of the femur in adults

KS P ISO 8637-2012

血液透析机、血液过滤机及血液浓缩机

Cardiovascular implants and extracorporeal   systems-Haemodialysers, haemodiafilters, haemofilters and   haemoconcentrators

KS P ISO 8638-2012

血液透析器、血液过滤器和血液浓缩器的体外血液回路

Cardiovascular implants and extracorporeal   systems -Extracorporeal blood circuit for haemodialysers, haemodiafilters   and haemofilters

KS P ISO 8669-1-2018

集尿袋第1部分:词汇

Urine collection bags-Part 1:Vocabulary

KS P ISO 8669-2-2018

集尿袋第2部分:要求和试验方法

Urine collection bags-Part 2:Requirements and test methods

KS P ISO 8670-1-2018

造口术收集袋第1部分:词汇

Ostomy collection bags-Part 1:Vocabulary

KS P ISO 8670-2-2018

造口术收集袋.第2部分:要求和试验方法

Ostomy collection bags — Part 2:   Requirements and test methods

KS P ISO 8827-2008

外科植入物.矫形用U形钉.一般要求

Implants for surgery-Staples with parallel   legs for orthopaedic use-General requirements

KS P ISO 8828-2008

外科植入物.矫形植入物的维护及交付指南

Implants for surgery-Guidance on care and   handling of orthopaedic implants

KS P ISO 8835-2-2009

吸入麻醉系统第2部分:成人麻醉呼吸系统

Inhalational anaesthesia systems-Part 2:Anaesthetic breathing systems for adults

KS P ISO 8835-3-2009

吸入麻醉系统第3部分:麻醉气体清除系统的传输和接收系统

Inhalational anaesthesia systems-Part 3:Transfer and receiving systems of anaesthetic gas scavenging   systemss

KS P ISO 8835-4-2010

吸入麻醉系统第4部分:麻醉蒸气输送装置

Inhalational anaesthesia systems-Part 4:Anaesthetic vapour delivery devices

KS P ISO 8835-5-2010

吸入麻醉系统第5部分:麻醉呼吸机

Inhalational anaesthesia systems-Part 5:Anaesthetic ventilators

KS P ISO 8836-2009

用于呼吸道的吸气引液导管

Suction catheters for use in the   respiratory tract

KS P ISO 8871-1-2010

非肠道和制药设备用弹性件第1部分:高压水溶液中的可萃取物

Elastomeric parts for parenterals and for   devices for pharmaceutical use-Part 1:Extractables   in aqueous autoclavates

KS P ISO 8871-2-2017

非肠道和制药设备用弹性件第2部分:识别和表征

Elastomeric parts for parenterals and for   devices for pharmaceutical use-Part 2:Identification   and characterization

KS P ISO 8871-3-2009

非肠道和制药设备用弹性件第3部分:释放粒子数的测定

Elastomeric parts for parenterals and for   devices for pharmaceutical use-Part 3:Determination   of released-particle count

KS P ISO 8871-4-2010

非肠道和制药设备用弹性件第4部分:生物学要求和试验方法

Elastomeric parts for parenterals and for   devices for pharmaceutical use-Part 4:Biological   requirements and test methods

KS P ISO 8871-5-2010

非肠道和制药设备用弹性件第5部分:功能要求和试验

Elastomeric parts for parenterals and for   devices for pharmaceutical use-Part 5:Functional   requirements and testing

KS P ISO 8872-2009

输血、输液和注射瓶铝盖.一般要求和试验方法

Aluminium caps for transfusion, infusion   and injection bottles-General requirements and test methods

KS P ISO 8980-1-2009

眼科光学未切边成品眼镜片第1部分:单焦和多焦镜片规范

Ophthalmic optics-Uncut finished   spectacle lenses-Part 1:Specifications   for single-vision and multifocal lenses

KS P ISO 9168-2012

牙科用气动牙科手机软管连接器

Dentistry-Hose connectors for air   driven dental handpieces

KS P ISO 9170-1-2012

医用气体管道系统用终端设备第1部分:与压缩医用气体和真空一起使用的终端设备

Terminal units for medical gas pipeline   systems-Part 1:Terminal units for use with   compressed medical gases and vacuum

KS P ISO 9170-2-2012

医用气体管道系统用终端设备第2部分:麻醉气体清除系统用终端设备

Terminal units for medical gas pipeline   systems-Part 2:Terminal units for anaesthetic gas   scavenging systems

KS P ISO 9173-1-2018

牙科学.拔牙钳.第1部分:一般要求

Dentistry — Extraction forceps — Part 1: General   requirements

KS P ISO 9173-2-2018

牙科学.拔牙钳.第2部分:名称与符号

Dentistry — Extraction forceps — Part 2:   Designation

KS P ISO 9173-3-2017

牙科学.拔牙钳.第3部分:设计

Dentistry ─ Extraction forceps - Part 3: Design

KS P ISO 9187-1-2014

医用注射设备第1部分:注射安瓿

Injection equipment for medical use — Part 1:   Ampoules for injectables

KS P ISO 9187-2-2014

医用注射设备第2部分:单点切割安瓿

Injection equipment for medical use-Part 2:One-point-cut(OPC) ampoules

KS P ISO 9268-2010

外科植入物.具有锥形下表面头部的金属接骨螺钉.尺寸

Implants for surgery-Metal bone screws with   conical under-surface of head-Dimensions

KS P ISO 9269-2010

外科植入物.金属接骨板.与锥形下表面螺钉对应的孔和槽

Implants for surgery-Metal bone plates-Holes and slots corresponding to screws with conical under-surface

KS P ISO 9333-2013

牙科-铜焊材料

Dentistry-Brazing materials

KS P ISO 9360-1-2009

麻醉和呼吸设备人体呼吸气体增湿用热湿交换器(HMEs)第1部分:最小潮气量为250毫升的热湿交换器

Anaesthetic and respiratory equipment-Heat and moisture   exchangers(HMEs) for humidifying respired gases in humans- Part 1:HMEs for use with minimum tidal   volumes of 250 mL

KS P ISO 9360-2-2009

麻醉和呼吸设备人体呼吸气体增湿用热湿交换器(HMEs)第2部分:最小潮气量为250毫升气管造口病人用热湿交换器

Anaesthetic and respiratory equipment-Heat and moisture   exchangers(HMEs) for humidifying respired gases in humans-Part 2:HMEs for use with tracheostomized   patients having minimum tidal volumes of 250 mL

KS P ISO 9394-2006

眼科光学.接触镜和接触镜保护产品.用兔眼视觉研究法测定生物相容性

Ophthalmic optics-Contact lenses and   contact lens care products- Determination of   biocompatibility by ocular study with rabbit eyes

KS P ISO 9583-2009

外科植入物无损检测金属外科植入物液体渗透检测

Implants for surgery-Non-destructive   testing-Liquid penetrant inspection of metallic   surgical implants

KS P ISO 9584-2009

外科植入物无损检测铸造金属外科植入物的射线照相检查

Implants for surgery-Non-destructive   testing-Radiographic examination of cast metallic   surgical implants

KS P ISO 9585-2010

外科植入物.骨板弯曲强度和刚度的测定

Implants for surgery-Determination of   bending strength and stiffness of bone plates

KS P ISO 9680-2017

牙科.工作灯

Dental operating light

KS P ISO 9687-2013

牙科用设备.图形符号

Dental equipment-Graphical symbols

KS P ISO 9693-2009

牙科用金属陶瓷充填料

Metal-ceramic dental restorative systems

KS P ISO 9713-2009

神经外科植入物.颅内动脉瘤自闭夹

Neurosurgical implants-Self-closing   intracranial aneurysm clips

KS P ISO 9714-1-2017

整形外科钻孔设备.第1部分:钻刃、丝锥和沉头铣刀

Orthopaedic drilling instruments-Part 1:Drill bits, taps and countersink cutters

KS P ISO 9873-2012

牙科手持器械.可重复使用的镜子和手柄

Dental hand instruments - Reusable mirrors   and handles

KS P ISO 9913-1-2014

光学和光学仪器.接触镜片.第1部分:用极谱法测定氧的渗透性和可传递性

Optics and optical instruments — Contact lenses   — Part 1: Determination of oxygen permeability and transmissibility with the   polarographic method

KS P ISO 9913-2-2014

光学和光学仪器.接触镜片.第2部分:用库仑法测定氧的渗透性和可透性

Optics and optical instruments — Contact lenses   — Part 2: Determination of oxygen permeability and transmissibility by the   coulometric method

KS P ISO 9917-1-2014

牙科学.水基胶粘剂.第1部分:动力/液体酸碱胶粘剂

Dentistry — Water-based cements — Part 1:   Power/liquid acid-base cements

KS P ISO 9917-2-2017

牙科水基胶粘剂第2部分:树脂改性胶粘剂

Dental-Water-based cements-Part 2:Resin-modified cements

KS P ISO 9997-2012

牙科卡式注射器

Dental cartridge syringes

KS P ISO 9999-2008

残疾人辅助用品分类和术语

Assistive products for persons with   disability-Classification and terminology

KS P ISO TR 11175-2010

牙科植入物.牙科植入物开发指南

Dental implants-Guidelines for   developing dental implants

KS P ISO TR 11548-1-2011

盲人用通信辅助器具8点盲文字符的识别、名称和编码字符集的分配第1部分:盲文识别和移位标志通用指南

Communication aids for blind persons-Identifiers, names and   assignation to coded character sets for 8-dot Braille characters-Part 1:General guidelines for Braille   identifiers and shift marks

KS P ISO TR 11548-2-2011

盲人用通信辅助器具8点盲文字符的识别、名称和编码字符集的分配第2部分:基于拉丁字母的字符集

Communication aids for blind persons-Identifiers, names and   assignation to coded character sets for 8-dot Braille characters-Part 2:Latin alphabet based character sets

KS P ISO TR 13668-2013

口腔卫生及护理用数字代码

Digital coding of oral health and care

KS P ISO TR 14283-2009

外科植入物.基本原则

Implants for surgery-Fundamental principles

KS P ISO TR 14569-1-2013

牙科材料磨损试验指南第1部分:刷牙磨损

Dental materials-Guidance on testing of   wear-Part 1:Wear by   toothbrushing

KS P ISO TR 14969-2008

医疗器械质量管理体系KS P应用指南ISO 13485:2007

Medical devices-Quality management   systems-Guidance on the application of KS P ISO   13485:2007

KS P ISO TR 15300-2013

牙科学OSI临床编码在牙科产品分类和编码中的应用

Dentistry-Application of OSI   clinical codification to the classification and coding of dental products

KS P ISO TR 15599-2013

牙科实验室程序的数字编码

Digital codification of dental laboratory   procedures

KS P ISO TR 16142-2007

医疗器械.医疗器械安全和性能公认基本原则的保障标准选用指南

Medical devices-Guidance on the   selection of standards in support of recognized essential principles of   safety and performance of medical devices

KS P ISO TR 16840-9-2017

轮椅座椅第9部分:座椅的临床界面压力绘图指南

Wheelchair seating ─ Part 9: Clinical interface pressure   mapping guidelines for seating

KS P ISO TR 18112-2009

临床实验室试验和体外诊断试验系统专业用体外诊断医疗器械制造商提供信息的管理要求摘要

Clinical laboratory testing and in vitro   diagnostic test systems-In vitro diagnostic medical devices for professional   use-Summary of regulatory requirements for   information supplied by the manufacturer

KS P ISO TR 22869-2009

医疗实验室.实验室实施KS P的指南.ISO 15189:2006

Medical laboratories-Guidance on laboratory   implementation of KS P ISO 15189:2006

KS P ISO TR 28642-2013

牙科颜色测量指南

Dentistry ― Guidance on colour measurement

KS P ISO TR 9586-2008

外科植入物.在矫形外科中"外翻足"和"内翻足"术语的应用

Implants for surgery-Usage of the terms   “valgus” and “varus” in orthopaedic surgery

KS P ISO TS 11139-2009

保健品灭菌术语

Sterilization of health care products-Vocabulary

KS P ISO TS 11405-2004

牙科材料.牙齿结构的附着力试验

Dental materials-Testing of adhesion to   tooth structure

KS P ISO TS 13498-2013

牙科学骨内种植体系统种植体/连接部位关节扭转试验

Dentistry ― Torsion test of implant   body/connecting part joints of endosseous dental implant systems

KS P ISO TS 14569-2-2014

牙科材料.磨损试验指南.第2部分:两和/或三体接触磨损

Dental materials — Guidance on testing of wear — Part 2:   Wear by two- and/or three body contact

KS P ISO TS 16782-2018

临床实验室试验—微生物药敏试验可接受的Mueller Hinton脱水琼脂和肉汤批标准

Clinical laboratory testing ─ Criteria for   acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial   susceptibility testing

KS P ISO TS 16840-11-2017

轮椅座椅第11部分:用于管理组织完整性的坐垫出汗消散特性的测定

Wheelchair seating ─ Part 11: Determination of perspiration   dissipation characteristics of seat cushions intended to manage tissue   integrity

KS P ISO TS 16840-12-2017

轮椅座椅.第12部分:坐垫包封试验的仪器和方法

Wheelchair seating — Part 12: Apparatus and method for   cushion envelopment testing

KS P ISO TS 16976-1-2010

呼吸保护装置人体因素第1部分:代谢率和呼吸流量

Respiratory protective devices-Human factors-Part 1:Metabolic rates and respiratory   flow rates

KS P ISO TS 17518-2018

医用实验室生物材料染色试剂使用指南

Medical laboratories ─ Reagents for   staining biological material ─ Guidance for users

KS P ISO TS 17822-1-2018

体外诊断试验系统基于核酸的微生物病原体定性检测和鉴定程序第1部分:一般要求、术语和定义

In vitro diagnostic test systems ─ Qualitative   nucleic acid-based in vitro examination procedures for detection and   identification of microbial pathogens ─ Part 1: General requirements, terms   and definitions

KS P ISO TS 19979-2006

眼科光学.接触镜片.由多位患者试用的接触镜片的卫生管理

Ophthalmic optics-Contact lenses-Hygienic management of multipatient use trial contact lenses

KS P ISO TS 20993-2009

医疗器械生物学评价风险管理过程指南

Biological evaluation of medical devices-Guidance on a risk-management process

KS P ISO TS 22367-2009

医学实验室通过风险管理和持续改进减少错误

Medical laboratories-Reduction of error   through risk management and continual improvement

KS P ISO TS 22595-1-2009

牙科-厂区设备-第1部分:抽吸系统

Dentistry-Plant area equipment-Part 1:Suction systems

KS P ISO TS 22595-2-2014

牙科学.厂区设备.第2部分:压缩机系统

Dentistry — Plant area equipment — Part 2:   Compressor systems

KS P ISO TS 22911-2014

牙科学牙科植入系统的临床前评价动物试验方法

Dentistry-Preclinical evaluation of   dental implant systems-Animal test methods

KS P ISO TS 23810-2009

心血管植入物和人工器官术前体外循环设备设置检查表

Cardiovascular implants and artificial   organs-Checklist for preoperative extracorporeal circulation equipment   setup

KS P ISO/TS 17988-2017

牙科学牙用汞齐腐蚀试验方法

Dentistry ─ Corrosion test methods for dental   amalgam

KS P ISO 5832-14-2009

统计方法符合规定要求的评定指南第1部分:总则

Statistical methods-Guidelines for the evaluation of   conformity with specified requirements-Part 1:General principles

KS P ISO 7176-10-2011

统计过程控制实施指南第1部分:统计过程控制要素

Guidelines for implementation of   statistical process control(SPC)-Part 1:Elements of SPC

KS P ISO 7176-11-2017

统计过程控制实施指南第2部分:工具和技术目录

Guidelines for implementation of   statistical process control(SPC)-Part 2:Catalogue of tools and techniques

KS P ISO 7176-13-2008

散装材料取样的统计方法第1部分:总则

Statistical aspects of sampling from bulk   materials-Part 1:General principles

KS P ISO 7176-14-2018

散装材料取样的统计方法第2部分:颗粒材料取样

Statistical aspects of sampling from bulk   materials-Part 2:Sampling of particulate materials

KS P ISO 7176-15-2008

检测能力第1部分:术语和定义

Capability of detection-Part 1:Terms   and definitions

KS P ISO 7176-16-2017

检测能力第2部分:线性校准情况下的方法学

Capability of detection-Part 2:Methodology   in the linear calibration case

KS P ISO 7176-19-2018

检测能力第3部分:无校准数据时响应变量临界值的确定方法

Capability of detection-Part 3:Methodology   for determination of the critical value for the response variable when no   calibration data are used

KS P ISO 7176-21-2010

检测能力第4部分:最小可检测值与给定值的比较方法

Capability of detection-Part 4:Methodology   for comparing the minimum detectable value with a given value

KS P ISO 7176-22-2018

检测能力第5部分:线性和非线性校准情况下的方法学

Capability of detection-Part 5:Methodology   in the linear and non-linear calibration cases

KS P ISO 7176-23-2008

检测能力.第7部分:基于仪器噪声随机特性的方法学

Capability of detection — Part 7: Methodology based on   stochastic properties of instrumental noise

KS P ISO 7176-24-2011

感官分析感官评价实验室工作人员通用指南第1部分:工作人员职责

Sensory analysis-General guidance for the staff of a   sensory evaluation laboratory-Part 1:Staff responsibilities

KS P ISO 7176-25-2017

感官分析感官评价实验室工作人员通用指南第2部分:小组组长的招聘和培训

Sensory analysis-General guidance for the staff of a   sensory evaluation laboratory-Part 2:Recruitment and training of panel leaders

KS P ISO 7176-26-2011

基于优先级分配原则(APP)的验收抽样程序第1部分:APP方法指南

Acceptance sampling procedures based on the   allocation of priorities principle(APP)-Part 1:Guidelines for the APP approach

KS P ISO 7206-10-2010

基于优先级分配原则的验收抽样程序第2部分:按属性进行验收抽样的协调单抽样方案

Acceptance sampling procedures based on the   allocation of priorities principle(APP)-Part 2:Coordinated single sampling plans   for acceptance sampling by attributes

KS P ISO 8536-10-2017

温室气体.第1部分:温室气体排放和清除的量化和报告的组织级指南规范

Greenhouse gases-Part 1:Specification   with guidance at the organization level for quantification and reporting of   greenhouse gas emissions and removals

KS P ISO 8536-11-2017

温室气体第2部分:减少或消除温室气体排放的量化、监测和报告的项目级指南规范

Greenhouse gases-Part 2:Specification   with guidance at the project level for quantification, monitoring and   reporting of greenhouse gas emission reductions or removal enhancements

KS P ISO 8536-12-2017

温室气体第3部分:温室气体断言的验证和验证指南规范

Greenhouse gases-Part 3:Specification   with guidance for the validation and verification of greenhouse gas   assertions

KS P ISO 8536-13-2018

数据的统计解释.第6部分:统计公差间隔的测定.第6部分:统计公差间隔的测定

Statistical interpretation of datadata — Part 6: Determination of statistical   tolerance intervals — Part 6: Determination of   statistical tolerance intervals