KS P 0107-2017

用于微生物病原体检测和鉴定的核酸体外诊断通用要求、术语和定义

Nucleic acid based in vitro diagnostics for   detection and identification of microbial pathogens ─ general requirements, terms and   definitions

KS P 0108-2017

微生物病原体检测和鉴定用核酸体外诊断实验室质量操作指南

Nucleic acid based in vitro diagnostics for   detection and identification of microbial pathogens ─ Laboratory quality practice guide

KS P 0234-2018

防褥垫:空气护垫型

Air mattresses for pressure sore prevention

KS P 0235-2007

假肢接口衬垫.第2部分:要求事项和测试方法

Socket liner for lower limb－Part 2：Requirements   and test methods

KS P 0236-2018

防褥疮坐垫:空气护垫型

Air cushions for pressure sore preventing   cushions

KS P 0387-2010

家庭疗养用手动床

Manually operated adjustable bed for home   care

KS P 0388-2012

家庭疗养用电动床

Electrically operated adjustable bed for   home care

KS P 1001-2006

医用道具切削和耐久力试验方法

Cut and durability test methods for   surgical knives

KS P 1002-2006

医用剪刀切剪力试验方法

Cut and durability test methods for   dressing scissors

KS P 1011-2008

重组细菌二维电泳检测方法

Test method of the 2-D electrophoresis for   recombinant bacteria

KS P 1012-2010

恶性疟原虫疟疾遗传诊断试验的质量控制标准材料

Standard materials for the quality control   of genetic diagnostic tests of Plasmodium falciparum malaria

KS P 1013-2010

恶性疟原虫疟疾抗原检测试验的质量控制标准参考材料

Standard reference materials for the   quality control of antigen detection tests of Plasmodium falciparum malaria

KS P 1014-2010

间日疟原虫疟疾抗原检测试验的质量控制标准参考材料

Standard reference materials for the   quality control of antigen detection tests of Plasmodium vivax malaria

KS P 1015-2018

肌钙蛋白心血管诊断参考资料的建立及评价方法

Establishment of a reference material and   evaluation method for troponin-based cardiovascular diagnostics

KS P 1017-2018

使用DNA微阵列的基因表达分析技术.一般要求和定义

The technology for gene expression analysis   using DNA microarrays —   General requirements and definitions

KS P 1018-2012

DNA微阵列基因表达分析技术基因组样品分离与质量控制方法

The technology for gene expression analysis   using DNA microarrays－Methods   for isolation of genomic samples and quality control

KS P 1019-2012

DNA微阵列基因表达分析技术－直接标记和测量基因表达的DNA微阵列实验程序

The technology for gene expression analysis   using DNA microarrays－Experimental   procedures for DNA microarrays with direct labelling and measurement of gene   expression

KS P 1021-2010

底部照相机

Fundus cameras

KS P 1101-2010

呼吸保护器的选择、使用及维修管理方法

Guidance for selection, use and maintenance   of respiratory protective devices

KS P 1102-2004

呼吸保护器术语

Glossary of terms relating to respiratory   protective equipments

KS P 1104-2006

呼吸用面罩泄漏率测试方法

Leakage rate testing method for facepieces   of respirstors

KS P 1231-2008

裂隙灯显微镜

Slit-lamp microscopes

KS P 1232-2008

手术用显微镜

Operation microscopes

KS P 1233-2008

硫化氢指示灯/报警器

Hydrogen sulfide indicator/alarm

KS P 1234-2008

供氧帐篷

Oxygen tents

KS P 1304-2010

医用气体软管组件

Hose assemblies for use with medical gas   systems

KS P 1305-2010

导管连接器

Tracheal tube connectors

KS P 1308-2009

造瘘术设备术语

Glossary of terms used in ostomy aids

KS P 1309-2009

造瘘术设备检测方法

Testing method for ostomy aids

KS P 1310-2-2004

气管切开导管.第2部:成人气管切开导管基本要求项目

Tracheostomy tubes－Part 2：Basic   requirements for tubes for adults

KS P 1509-2014

针对老人的家居设施的设计尺寸原则和标准

Principle and recommendation for designing   dimension of dwelling in consideration of the elderly

KS P 1600-2007

抗生素安全性测试的一般通用标准

General guideline of safety test for the   cell based therapeutic substances

KS P 1800-2013

体外诊断试验基质效应评价方案

Protocol for evaluation of matrix effects   in in-vitro diagnostic test

KS P 1801-2013

化学分析设备维护要求

Requirements for maintenance of chemical   analysis equipments

KS P 1907-1-2017

输液管药物吸附测定方法第1部分：硝化甘油、环孢菌素A、他克莫司

Determination method of drug adsorption in   infusion tube ─ Part1: Nitroglycerin,   Cyclosporin A, Tacrolimus

KS P 1927-2017

中药饮片机

Herbal decoction apparatus

KS P 1928-2017

韩国医学艾灸器通用要求

Korean Medicine ─ General requirements of moxibustion   devices

KS P 1975-2018

体外诊断医学实验室定量试验精密性能评价规程

Protocol for evaluation of precision   performance of the quantitative test in in-vitro diagnostic medical   laboratory

KS P 1977-2018

体外诊断医学实验室定性试验性能评价规程

Protocol for evaluation of qualitative test   performance in in-vitro diagnostic medical laboratory

KS P 2000-2012

东方医学针灸治疗安全管理指南

Safety management guideline for acupuncture   treatment in oriental medicine

KS P 2001-2006

外科用刀

Surgical knives

KS P 2002-2017

医用刀

Medical knives

KS P 2003-2006

眼科用刀

Eye knives

KS P 2005-2008

医用剪刀

Surgical scissors

KS P 2008-2009

医用敷料镊

Medical dressing forceps

KS P 2009-2009

医用镊

Medical forceps

KS P 2011-2008

手术针支架

Surgical needle holders

KS P 2014-2006

探针

Probes

KS P 20160-2010

外科植入物金属材料α+β钛合金棒显微结构分类

Implants for surgery－Metallic materials－Classification of microstructures for alpha+beta titanium alloy   bars

KS P 2101-2006

刮骨膜刀

Periosteal raspatories

KS P 2103-2009

尿道切开刀

Urethrotormies

KS P 2104-2009

尿道口切开用圆刀

Urethral knives

KS P 2105-2010

皮肤划痕器

Scarificators

KS P 2601-2007

血针

Blood lancet

KS P 2603-2008

医用吊钩

Medical hooks

KS P 2604-2008

医用刮匙

Medical curettes

KS P 2607-2008

医用电梯

Medical elevators

KS P 2609-2007

子宫刮刀

Uterine curettes sharp

KS P 2611-2010

粉刺提出器

Comedo extractor

KS P 2612-2006

动脉瘤针

Aneurism needles

KS P 2613-2006

结扎线导流器

Ligature carrier

KS P 2615-2008

医用牵开器

Medical retractor

KS P 2617-2009

眼科用剪刀

Eye scissors

KS P 2618-2017

眼科用钳

Eye forceps

KS P 2619-2009

泪腺针探

Lacrimal probe

KS P 2801-2007

扁桃体勒除器

Tonsil snares

KS P 3001-2007

一次性注射针

Disposable injection needles

KS P 3003-2010

听诊器

Stethoscopes

KS P 3004-2009

一次性塑料注射器

Disposable plastic syringe

KS P 3005-2006

外科用缝合针

Surgical needles suture

KS P 3006-2008

套管针

Trocars

KS P 3008-2010

耳针

Ear acupuncture needles

KS P 3009-2010

皮内针

Intradermal acupuncture needles

KS P 3010-2012

人体穴位名称与位置十四经

Human acupuncture point names and locations－The fourteen meridian

KS P 3011-2018

子宫刮匙

Uterine curettes

KS P 3012-2007

子宫升运器

Uterine elevator

KS P 3013-2007

子宫颈扩张器

Uterine cervicel dilaters

KS P 3015-2010

外科用丝绸缝线

Surgical silk suture

KS P 3016-2006

外科用肠线

Surgical sutures catgut

KS P 3101-2008

肛门镜

Anoscope

KS P 3102-2017

阴道镜

Vaginal specula

KS P 3103-2006

腹部窥器

Abdominal speculum

KS P 3104-2018

温灸器

Moxa cautery apparatus

KS P 3105-2017

扁桃体切除器

Tonsilotomes

KS P 3106-2006

医用离心分离机

Centrifuge for medical use

KS P 3107-2006

压舌板

Tongue depressors

KS P 3205-2017

耳鼻科用插管

Cannula for maxillary antrum and frontal   sinus

KS P 3207-2009

膀胱洗涤器

Urinary bladder syringes

KS P 3208-2010

皮肤环钻

Skin trephines

KS P 3501-2017

医用锉刀

Bone files

KS P 3502-2008

医用凿子

Medical chisels

KS P 3503-2018

冷冻治疗仪探头

Cryocautery tip

KS P 3504-2007

脓盆

Pus basins

KS P 3505-2017

洗眼盘

Eye dressing trays

KS P 3506-2009

消毒盘

Sterilizing trays

KS P 4201-2010

瘀点计

Petechiometers

KS P 4204-2010

血球计数器

Haemocytometer

KS P 4205-2010

血色素计

Haemometers

KS P 4401-2007

检眼镜片箱

Settled lens set

KS P 4402-2007

测试镜片组

Test lens set

KS P 4404-2009

太阳眼镜镜片

Lenses for sunglass

KS P 4405-2010

检眼镜

Ophthalmoscopes

KS P 4406-2010

视力测试仪

Visual acuity testing equipments

KS P 4407-2018

膀胱镜

Cystoscopes

KS P 4408-2018

胃镜

Gastroscopes

KS P 4901-2007

医用音叉

Tuning forks(for medical use)

KS P 4902-2018

外科用锯

Surgical saws

KS P 4905-2006

气管内导管.柯尔式

Tracheal tubes－Cole type

KS P 4906-2006

医疗设备生产者用不锈钢针管

Stainless steel needle tubing for   manufacture of medical devices

KS P 5101-2010

牙科用镍铬合金板

Nickel-chrominum alloy plates for dental   use

KS P 5102-2004

牙科诊断用X光机

Diagnostic X-ray generators for dental use

KS P 5105-2017

牙科铸造用金银钯合金

Dentistry－Dental casting gold-silver-palladium alloy

KS P 5106-2017

牙科铸造用锡合金

Dentistry－Dental casting tin alloy

KS P 5107-2007

牙科成形充填器

Dental plastic

KS P 5109-2007

牙科凿

Dental chisel

KS P 5203-2017

牙科用可熔合金

Dentistry－Fusible alloy

KS P 5206-2017

牙科用暂封牙胶条

Dental temporary stopping

KS P 5208-1992

牙科用金冠剪

Dental crown scissors

KS P 5209-2017

牙科用不锈钢线

Stainless steel wires for dental use

KS P 5210-1995

牙科用钴铬合金线

Cobalt-chromium alloy wires for dental use

KS P 5212-1995

牙科铸造用14k金合金

Plus metals for dental casting 14K gold   alloys

KS P 5301-2017

补牙丙烯酸树脂

Dentistry－Acrylic denture base resins

KS P 5302-2017

牙科用铸造用蜡嵌体

Dentistry－Casting wax

KS P 5305-2017

牙科用薄蜡片

Dentistry－Dental sheet wax

KS P 5308-1995

牙科用镍铬合金线

Nickel-chromium alloy wires for dental use

KS P 5309-2017

牙科铸造用银合金

Dentistry－Dental casting silver alloys

KS P 5310-2017

牙科加工用金银钯合金

Dentistry－Dental wrought gold-silver-palladium alloy

KS P 5311-2017

牙科用金银钯和金焊

Dentistry－Dental gold-silver-palladium alloy solders

KS P 5312-2017

牙科自凝牙托树脂

Dentistry－Self curing acrylic resin for crown

KS P 5318-2008

牙科印模化合物

Dental impression compound

KS P 5321-2004

牙科用机头.耦合尺寸

Dental handpieces－Coupling dimensions

KS P 5322-1-2004

牙科用机头.第1部:高速气动涡轮机头

Dental handpieces－Part 1：High-speed   air-turbine handpieces

KS P 5322-2-2004

牙科用机头.第2部:直柄和齿轮角柄

Dental handpieces－Part 2：Straight   and geared angle handpieces

KS P 6022-2018

X射线胶片照明器

Illuminator for X-ray film

KS P 6023-2018

诊疗用X射线防护围裙

Medical X-ray protective aprons

KS P 6024-2007

诊疗用X射线防护屏

Medical X-ray protective screens

KS P 6101-2017

医用煮沸消毒器

Boiling and steam sterilizer

KS P 6102-2009

高压蒸汽消毒器

High-pressure steam sterilizers for medical   use

KS P 6104-2018

酒精棉容器

Alcohol-cotton case

KS P 6105-2018

导管

Catheters

KS P 6106-2010

医用探条及导管标准尺寸

Standard scale for medical bougie and   catheter

KS P 6107-2010

额镜带反光镜

Reflectors with head band

KS P 6108-2010

药品、血库冰箱及冷冻器

Blood and pharmacy storage electric   refrigerator and freezers

KS P 6111-2017

孵箱

Incubator

KS P 6112-2018

分娩台

Obstetric delivery table

KS P 6113-2018

手动轮椅

Human-driven wheelchairs

KS P 6114-2014

电动轮椅

Electrically powered wheelchairs, scooters   and their chargers —   Requirements and test methods

KS P 6115-2006

医用氧化乙烯气体消毒器

Ethylene oxide gas sterilizers for medical   use

KS P 6116-2006

医用氧化乙烯气体消毒器(小型)

Ethylene oxide gas sterilizers for medical   use(Small size)

KS P 6117-2006

检眼镜

Retinoscopes

KS P 6118-2006

大型弱视镜

Major amblyoscopes

KS P 6119-2006

鼻塞测压计

Rhinomanometers

KS P 6120-2006

高压治疗舱

Hyperbaric oxygen chambers

KS P 6123-2006

心肺分流术（体外循环）用电动血液泵

Electric motor driven blood pump for   cardiopulmonary bypass

KS P 6124-2006

医用氧气浓度计

Oxygen analyzers for medical use

KS P 6127-2006

手动复苏器

Manual(operator－powered) resuscitators

KS P 6128-2006

气动复苏器

Gas－powered resuscitators

KS P 6130-2009

医用小型蒸汽灭茵器

Table-top steam sterilizers

KS P 6131-2009

医用大型蒸汽灭茵器

Hospital steam sterilizers

KS P 6201-2017

手术台（改造型）

Operating table

KS P 6202-2017

无影灯

Shadowless lamp

KS P 6203-2006

吸引器

Suction apparatus

KS P 6311-2017

便携式过滤型吸尘器

Portable filter type dust and fume   collectors

KS P 7109-2012

牙科电钻机

Electric dental engines

KS P 7114-2010

牙科用痰盂

Dental spittoon

KS P 7115-2017

牙科用碳化硅尖

Dental carborundum points

KS P 7116-1990

牙科用调拌刀

Dental wax spatulas

KS P 7117-2017

齿冠用加热固化丙烯树脂

Dentistry－Dental heat curing acrylic resin for crown

KS P 7203-2008

麻醉机

Anesthetic machines

KS P 7209-2007

牙科用碳化硅轮

Dental carborundum wheels

KS P 7304-2010

胃肠缝合工具

Gastrointestinal sewing tools

KS P 7408-2007

牙科用骨锉

Dental bone files

KS P 7409-2007

牙科用骨髓针托架

Dental broach holders

KS P 7412-2007

牙科用手术刀

Dental operating knives

KS P 7415-2007

牙科用卷棉子

Gingival applicators

KS P 7418-2017

牙科铸造用合金.钴铬合金

Dentistry－Base metal casting alloys－Part   1：Cobalt-based alloys

KS P 7419-2012

牙科学磷酸钙水泥

Dentistry－Calcium phosphate cements

KS P 7420-2010

牙科用氧化锌-丁香酚牙印模糊剂

Dental impression paste-zinc oxide-engenol   type

KS P 7424-2008

牙科用金合金焊料

Dental gold alloy solders

KS P 7429-1995

牙周袖珍探针

Periodontal pocket probes

KS P 7436-1995

牙科用橡皮障夹

Dental rubber dam clamps

KS P 7437-1995

牙科用牙托

Dental impression trays

KS P 7448-1999

齿冠用常温补牙树脂

Dental self­curing acylic resin for crown

KS P 8002-2006

绷带

Bandage

KS P 8003-2007

脱脂棉

Cotton absorbent

KS P 8004-2009

输液器

Intravenous infusion set

KS P 8005-2008

纱布

Gauze

KS P 8006-2009

输血器

Blood recipient set

KS P 8007-2007

输液泵

Infusion pumps

KS P 8010-2007

绝缘保护设备及防护设备的耐电压试验法

Testing method for withstand voltage of   personal protective equipment and insulating devices

KS P 8141-2012

防射线用眼睛防护罩

Eye protectors for radiations

KS P 8142-2007

焊接用安全帽面罩和手持面罩

Helmet type and handshield type protectors   for welders

KS P 8147-2008

护目镜

Eye protector

KS P 8153-2010

供气口罩

Supplied-air respirators

KS P 8155-2009

呼吸设备

Compressed air open-circuit self-contained   breathing apparatus

KS P 8161-2010

护耳器

Ear protectors

KS P 8165-2008

线路维修工用安全带

Safety belts for line-men

KS P 8201-2006

氧气浓度计

Oxygen indicator/alarm

KS P 8202-2006

普通风速计

Anemometer for general use

KS P 8305-2006

担架

Holding stretchers

KS P 8306-2017

哺乳瓶

Feeding bottles

KS P 8401-2007

木拐杖

Wooden axilla crutches

KS P 8403-2007

假肢脚和踝

Prosthetic feet and ankle joints

KS P 8404-2007

假肢膝盖

Artificial knees

KS P 8405-2007

医用踏旋器

Medical treadmils

KS P 8406-2005

下肢假肢的金属踝关节

Metallic ankle joints for lower extremity   orthoses

KS P 8407-2005

下肢假肢的金属镫骨

Stirrups for lower extremity orthoses

KS P 8408-2005

下肢假肢的金属膝关节

Metallic knee joints for lower extremity   orthoses

KS P 8409-2007

随意钩

Voluntary opening hooks

KS P 8410-2007

随意柄

Voluntary opening hands

KS P 8411-2007

外部锁闭肘功能铰链

Outside locking elbow hinge units

KS P 8412-2018

控制电缆系统

Control cable system units

KS P 8413-2007

肘功能铰链

Functional elbow units

KS P 8414-2007

手腕设备

Wrist units

KS P 8415-2007

假手用装饰手套

Cosmetic gloves for artificial hands

KS P 8416-2008

微粒子用防尘口罩

Dust respirators for fine particles

KS P 8417-2008

电动净化空气防尘面具

Powered air purifying respirators(PAPR)

KS P 8418-2008

制氧闭路呼吸器

Oxygen-generating closed-circuit breathing   apparatus

KS P 8420-2008

假臂装饰假手

Cosmetic hands for arm prostheses

KS P 8421-2006

假肢接口衬垫.第1部分:术语和分类

Socket liner for lower limb－Part 1：Terms   and classification

KS P 8422-2014

牙科学.牙科植入系统的连接螺钉

Dentistry — Connecting screw of endosseous dental implant system

KS P 8423-2014

牙科学.CAD/CA系统的互操作性

Dentistry — Interoperability of CAD/CA systems

KS P 8424-2014

牙科学-鼻窦提升机

Dentistry — Sinus elevator

KS P 8425-2015

牙科学.牙科修复材料荧光测定的试验方法

Dentistry — Test methods for determining fluorescence of dental   restorative materials

KS P 8426-2015

牙科学.牙科手机.防污染的防回吸试验方法

Dentistry — Dental handpieces —   Anti-suckback test methods for anti-contamination

KS P 8427-2015

牙科学.正畸金属小螺钉.扭矩和多角度拔出强度的试验方法

Dentistry — Orthodonticmetallic mini screw — Test methods of torque and multiangularpull-out strength

KS P 8428-2015

临床实验室自动化系统性能通用要求

General requirements for clinical   laboratory automation system performance

KS P 8429-2015

临床实验室自动化系统信息通用要求

General requirements for clinical   laboratory automation system information

KS P 8430-2015

临床实验室分析前自动化系统管理及安全要求

Management and safety requirements for   clinical laboratory pre-analytical automation system

KS M ISO 6743-14-2008

医用吸引设备.第1部分：电动吸引设备

Medical suction equipment — Part 1:Electrically powered suction   equipment

KS M ISO 6743-15-2009

牙科学可摘义齿软衬材料第1部分：短期使用材料

Dentistry－Soft lining materials for removable dentures－Part 1：Materials for short-term use

KS M ISO 6743-3A-2008

牙科学可摘义齿软衬材料第2部分：长期使用材料

Dentistry－Soft lining materials for removable dentures－Part 2：Materials for long-term use

KS P ISO 10271-2004

牙科金属材料.抗腐蚀试验方法

Dentistry－Determination of tarnish and corrosion of metal and   alloys

KS P ISO 10310-2010

神经外科植入物.可植入神经刺激器的标记和包装

Neurosurgical implants－Marking and packaging of implantable   neural stimulators

KS P ISO 10323-2014

牙科旋转器械.切盘和轮的内径

Dental rotary instruments－Bore diameters for discs and wheels

KS P ISO 10328-2009

假肢下肢假肢的结构试验要求和试验方法

Prosthetics－Structural testing of lower－limb   prostheses－Requirements and test methods

KS P ISO 10334-2010

外科植入物.缝合和其他外科用金属丝

Implants for surgery－Malleable wires for use as sutures   and other surgical applications

KS P ISO 10342-2002

眼科仪器.眼睛折射计

Ophthalmic instruments－Eye refractometers

KS P ISO 10343-2002

眼科仪器.检眼仪

Ophthalmic instruments－Ophthalmometers

KS P ISO 10451-2012

牙科植入系统.技术文件内容

Dentistry－Contents of technical file for dental implant systems

KS P ISO 10477-2009

牙科聚合物基冠桥材料

Dentistry－Polymer-based crown and bridge materials

KS P ISO 10535-2009

残疾人转移用提升机要求和试验方法

Hoists for the transfer of persons with   disability－ Requirements and test   methods

KS M ISO 8502-10-2002

残疾人技术系统和辅助器具轮椅系紧和轮椅使用者约束系统第1部分：所有系统的要求和试验方法

Technical systems and aids for disabled or   handicapped persons —   Wheelchair tiedown and occupant-restraint systems —   Part 1: Requirements and test methods for all systems

KS P IEC 60601-2-2001

一次性使用无菌血管内导管第1部分：一般要求

Sterile, single-use intravascular catheters－Part 1：General   requirements

KS P IEC 60601-2-2002

一次性使用无菌血管内导管第3部分：中心静脉导管

Sterile, single-use intravascular catheters－Part 3：Central   venous catheters

KS P IEC 60601-2-2002

一次性使用无菌血管内导管第4部分：球囊扩张导管

Sterile, single-use intravascular catheters－Part 4：Balloon   dilatation catheters

KS P ISO 10079-1-2017

一次性使用无菌血管内导管第5部分：针外周导管

Sterile, single-use intravascular catheters－Part 5：Over-needle   peripheral catheters

KS P ISO 10637-2012

牙科设备.高和中容量抽吸系统

Dental equipment－Highand mediumvolume suction systems

KS P ISO 10139-1-2008

牙科动力聚合活化剂第1部分：石英卤钨灯

Dentistry－Powered polymerization activators－Part 1：Quartz tungsten halogen lamps

KS P ISO 10139-2-2004

牙科动力聚合活化剂第2部分：发光二极管（LED）灯

Dentistry－Powered polymerization activators－Part 2：Light-emitting diode(LED) lamps

KS P ISO 10328-2-2004

医用肺换气扇第3部分：急救和运输用换气扇的特殊要求

Lung ventilators for medical use－Part 3：Particular   requirements for emergency and transport ventilators

KS P ISO 10328-3-2004

肺通气机第4部分：操作者驱动的复苏器的特殊要求

Lung ventilators－Part 4：Particular   requirements for operator-powered resuscitators

KS P ISO 10328-4-2004

医用肺换气扇基本安全和基本性能的特殊要求第5部分：气动紧急复苏器

Lung ventilators for medical use－Particular requirements for basic   safety and essential performance－Part 5：Gas-powered emergency resuscitators

KS P ISO 10328-5-2004

为坐着和站着的乘客设计的无障碍运输车辆的轮椅封闭和乘客保留系统.第2部分：前向轮椅坐着乘客的系统

Wheelchair containment and occupant   retention systems for accessible transport vehicles designed for use by both   sitting and standing passengers — Part 2: Systems for forward-facing wheelchair-seated passengers

KS P ISO 10873-2018

牙科－义齿粘合剂

Dentistry－Denture adhesives

KS P ISO 10939-2002

眼科仪器.裂隙灯显微镜

Ophthalmic instruments－Slit-lamp microscopes

KS P ISO 10985-2009

铝塑组合输液瓶和注射瓶盖.要求和试验方法

Caps made of aluminium-plastics   combinations for infusion bottles and injection vials－Requirements and test methods

KS P ISO 10328-6-2004

医疗器械生物学评价第1部分：风险管理过程中的评价和试验

Biological evaluation of medical devices — Part 1: Evaluation and testing   within a risk management process

KS P ISO 10993-10-2018

医疗器械的生物学评价.第10部分：刺激和皮肤致敏试验

Biological evaluation of medical devices — Part 10: Tests for irritation and   skin sensitization

KS P ISO 10993-11-2007

医疗器械生物学评价第11部分：全身毒性试验

Biological evaluation of medical devices－Part 11：Tests   for systemic toxicity

KS P ISO 10993-12-2014

医疗器械的生物学评价.第12部分：样品制备和参考材料

Biological evaluation of medical devices — Part 12: Sample preparation and   reference materials

KS P ISO 10993-13-2018

医疗器械的生物学评价.第13部分：聚合医疗器械降解产物的识别和定量

Biological evaluation of medical devices — Part 13: Identification and   quantification of degradation products from polymeric medical devices

KS P ISO 10993-14-2017

医疗器械生物学评价第14部分：陶瓷降解产物的识别和定量

Biological evaluation of medical devices — Part14:Identification and   quantification of degradation products from ceramics

KS P ISO 10993-15-2006

医疗器械生物学评价第15部分：金属和合金降解产物的定性和定量

Biological evaluation of medical devices－Part 15：Identification   and quantification ofdegradation products from metals and alloys

KS P ISO 10993-16-2017

医疗器械生物学评价第16部分：降解产物和可沥滤物的毒理动力学研究设计

Biological evaluation of medical devices — Part16:Toxicokinetic study design   for degradation products and leachables

KS P ISO 10993-17-2017

医疗器械的生物学评价.第17部分：可沥滤物质容许限值的确定

Biological evaluation of medical devices — Part 17：Establishment   of allowable limits for leachable substances

KS P ISO 10993-18-2009

医疗器械生物学评价第18部分：材料的化学特性

Biological evaluation of medical devices－Part 18：Chemical   characterization of materials

KS P ISO 10993-19-2009

医疗器械生物学评价第19部分：材料的理化、形态和地形特征

Biological evaluation of medical devices－Part 19：Physico-chemical,   morphological and topographical characterization of materials

KS P ISO 10328-7-2004

医疗器械生物学评价第2部分：动物福利要求

Biological evaluation of medical devices－Part 2：Animal   welfare requirements

KS P ISO 10993-20-2009

医疗器械生物学评价第20部分：医疗器械免疫毒理学试验的原则和方法

Biological evaluation of medical devices－Part 20：Principles   and methods for immunotoxicology testing of medical devices

KS P ISO 10328-8-2004

医疗器械生物学评价第3部分：遗传毒性、致癌性和生殖毒性试验

Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity   and reproductive toxicity

KS P ISO 10542-1-2017

医疗器械生物学评价第4部分：与血液相互作用试验的选择

Biological evaluation of medical devices－Part 4：Selection   of tests for interactions with blood

KS P ISO 10542-2-2005

医疗器械生物学评价第5部分：体外细胞毒性试验

Biological evaluation of medical devices — Part 5: Tests for in vitro   cytotoxicity

KS P ISO 10542-3-2011

医疗器械生物学评价第6部分：植入后局部效应试验

Biological evaluation of medical devices — Part 6: Tests for local effects   after implantation

KS P ISO 10542-4-2011

医疗器械生物学评价第7部分：环氧乙烷灭菌残留量

Biological evaluation of medical devices－Part 7：Ethylene   oxides sterilization residuals

KS P ISO 10555-1-2007

医疗器械的生物学评价.第9部分：潜在降解产品的识别和量化框架

Biological evaluation of medical devices — Part 9: Framework for identification   and quantification of potential degradation products

KS P ISO 10555-2-2007

预灌装注射器.第1部分：牙科局部麻醉药筒用玻璃瓶

Prefilled syringes — Part 1: Glass cylinders for dental   local anaesthetic cartridges

KS P ISO 10555-3-2007

预灌装注射器.第2部分：牙科局部麻醉药筒用柱塞塞

Prefilled syringes — Part 2: Plunger stoppers for dental   local anaesthetic cartridges

KS P ISO 10555-4-2007

预灌装注射器.第3部分：牙科局部麻醉药筒的密封件

Prefilled syringes — Part 3: Seals for dental local   anaesthetic cartridges

KS P ISO 10555-5-2007

预灌装注射器第4部分：注射用玻璃桶

Prefilled syringes－Part 4：Glass   barrels for injectables

KS P ISO 10650-1-2012

预灌装注射器.第5部分：注射剂用柱塞塞

Prefilled syringes — Part 5: Plunger stoppers for   injectables

KS P ISO 10650-2-2009

预灌装注射器第6部分：注射用塑料桶

Prefilled syringes ─ Part 6: Plastic barrels for   injectables

KS P ISO 10651-1-2002

预灌装注射器第7部分：可灌装的无菌分组件注射器的包装系统

Prefilled syringes ─ Part7: Packaging systems for   sterilized subassembled syringes ready for filling

KS P ISO 10651-3-2008

预灌装注射器第8部分：成品成型注射器的要求和试验方法

Prefilled syringes ─ Part 8: Requirements and test   methods for finished profilled syringes

KS P ISO 11135-2008

医疗器械环氧乙烷灭菌验证及常规控制

Medical devices－Validation and routine control of   ethylene oxide sterilization

KS P ISO 10651-5-2008

医疗保健产品灭菌－辐射－第1部分：医疗器械灭菌过程的开发、验证和常规控制要求

Sterilization of health care products－Radiation－Part   1：Requirements for development, validation and   routine control of a sterilization process for medical devices

KS P ISO 10865-2-2017

保健品灭菌－辐射－第2部分：确定灭菌剂量

Sterilization of health care products－Radiation－Part   2：Establishing the sterilization dose

KS P ISO 10993-1-2018

医疗保健产品灭菌－辐射－第3部分：剂量测定指南

Sterilization of health care products－Radiation－Part   3：Guidance on dosimetric aspects

KS P ISO 10993-2-2010

医疗保健产品灭菌生物指示物第1部分：一般要求

Sterilization of health care products－Biological indicators－Part 1：General requirements

KS P ISO 10993-3-2018

保健品灭菌生物指示物第2部分：环氧乙烷灭菌过程生物指示物

Sterilization of health care products－Biological indicators－Part 2：Biological indicators for ethylene   oxide sterilization processes

KS P ISO 10993-4-2017

医疗保健产品灭菌生物指示物第3部分：湿热灭菌过程生物指示物

Sterilization of health care products－Biological indicators－Part 3：Biological indicators for moist   heat sterilization processes

KS P ISO 10993-5-2018

保健品灭菌生物指示物第5部分：低温蒸汽和甲醛灭菌过程用生物指示物

Sterilization of health care products－Biological indicators－Part 5：Biological indicators for   low-temperature steam and formaldehyde sterilization processes

KS P ISO 10993-6-2018

医疗保健产品灭菌化学指标第1部分：一般要求

Sterilization of health care products－Chemical indicators－Part 1：General requirements

KS P ISO 10993-8-2002

医疗保健产品灭菌化学指示剂第3部分：鲍伊和迪克型蒸汽渗透试验用2级指示剂系统

Sterilization of health care products－Chemical indicators－Part 3：Class 2 indicator systems for use   in the Bowie and Dick-type steam penetration test

KS P ISO 10993-9-2018

医疗保健产品灭菌化学指示剂第4部分：蒸汽渗透检测用2级指示剂替代鲍伊和迪克型式试验

Sterilization of health care products－Chemical indicators－Part 4：Class 2 indicators as an   alternative to the Bowie and Dick-type test for detection of steam   penetration

KS P ISO 11040-1-2018

医疗保健产品灭菌化学指示剂第5部分：鲍伊和迪克型除气试验用2级指示剂

Sterilization of health care products－Chemical indicators－Part 5：Class 2 indicators for Bowie and   Dick-type air removal tests

KS P ISO 11143-2018

牙科学.汞齐合金分离器

Dentistry — Amalgam separators

KS P ISO 11195-2008

医用气体混合器.独立气体混合器

Gas mixers for medical use－Stand-alone gas mixers

KS P ISO 11040-2-2018

双臂操作的助步器.要求和试验方法.第1部分：步行架

Walking aids manipulated by both arms — Requirements and test methods — Part 1: Walking frames

KS P ISO 11040-3-2018

双臂操作的助步器.要求和试验方法.第2部分：滚动器

Walking aids manipulated by both arms — Requirements and test methods — Part 2: Rollators

KS P ISO 11040-4-2009

双臂操作的助步器要求和试验方法第3部分：步行台

Walking aids manipulated by both arms — Requirements and test methods — Part 3: Walking tables

KS P ISO 11318-2012

心脏除颤器.可植入体内的心脏除颤器联接器系统.尺寸和试验

Cardiac defibrillators－Connector assembly DF-1 for   implantable defibrillators－Dimensions and test   requirements

KS P ISO 11040-5-2014

单臂操作助步器要求和试验方法第1部分：肘拐杖

Walking aids manipulated by one arm－Requirements and test methods－Part 1：Elbow crutches

KS P ISO 11040-6-2018

单臂操作助步器第4部分：三条腿或更多条腿的助步器

Walking aids manipulated by one arm－Part 4：Walking   sticks with three or more legs

KS P ISO 1135-3-2009

医用输液设备第3部分：采血器

Transfusion equipment for medical use－Part 3：Blood-taking   set

KS P ISO 1135-4-2014

医用输血设备.第4部分：一次性使用输血器

Transfusion equipment for medical use — Part 4: Transfusion sets for single   use

KS P ISO 11040-7-2018

药品配制用容器及附件第1部分：滴注玻璃瓶

Containers and accessories for   pharmaceutical preparations－Part 1：Drop-dispensing glass bottles

KS P ISO 11040-8-2018

药品配制用容器及附件第2部分：糖浆用螺纹颈玻璃瓶

Containers and accessories for   pharmaceutical preparations－Part 2：Screw-neck glass bottles for syrups

KS P ISO 11135-1-2014

药品配制容器及附件第3部分：固体和液体剂型螺纹颈玻璃瓶（veral）

Containers and accessories for   pharmaceutical preparations－ Part 3：Screw-neck glass bottles (veral)   for solid and liquid dosage forms

KS P ISO 11137-1-2008

药品配制用容器及附件第4部分：平板玻璃瓶

Containers and accessories for   pharmaceutical preparations－Part 4：Tablet glass bottles

KS P ISO 11137-2-2014

药品配制用容器及附件第5部分：滴管组件

Containers and accessories for   pharmaceutical preparations－Part 5：Dropper assemblies

KS P ISO 11137-3-2008

药品配制用容器及附件第7部分：液体剂型用玻璃管螺纹颈瓶

Containers and accessories for   pharmaceutical preparations－Part 7：Screw-neck vials made of glass   tubing for liquid dosage forms

KS P ISO 11499-2017

牙科局部麻醉用一次性药筒

Dentistry－Single-use cartridges for local anaesthetics

KS P ISO 11138-1-2012

最终灭菌医疗器械的包装第1部分：材料、无菌屏障系统和包装系统的要求

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

KS P ISO 11138-2-2012

最终灭菌医疗器械包装第2部分：成型、密封和组装工艺的验证要求

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

KS P ISO 11609-2012

牙膏.要求、试验方法和标志

Dentistry－Dentifrices－Requirements, test   methods and marking

KS P ISO 11663-2017

血液透析用透析液质量及相关治疗

Quality of dialysis fluid for haemodialysis   and related therapies

KS P ISO 11138-3-2012

医疗器械灭菌微生物学方法第1部分：产品微生物总数的测定

Sterilization of medical devices－Microbiological methods－Part 1：Determination of population of   microorganisms on products

KS P ISO 11138-5-2009

医疗器械灭菌微生物学方法第2部分：灭菌过程验证中的无菌试验

Sterilization of medical devices－Microbiological methods－Part 2：Tests of sterility performed in the   validation of a sterilization process