標(biāo)準(zhǔn)號(hào) |
中文名稱 |
英文名稱 |
| NF S96-310-1999 |
單臂操作的助步器.要求和試驗(yàn)方法. 第4部分:具有三條或多于三條腿支撐的扶杖 |
(Walking aids manipulated by one arm. Requirements and test methods. Part 4 : walking sticks with three or more legs.) |
| NF S96-632-2001 |
吸尿輔助器.從使用者和護(hù)理者的角度評(píng)價(jià)一次性使用的成人不能自制的輔助器的基本原則 |
(Urine-absorbing aids - Basic principles for evaluation of single-use adult-incontinence-absorbing aids from the perspective of users and caregivers.) |
| NF S96-800-1999 |
外假肢和外矯形.要求和試驗(yàn)方法(歐洲標(biāo)準(zhǔn)EN 12523) |
(External limb prostheses and external orthoses. Requirements and test methods.) |
| NF S97-001-2001 |
一次性醫(yī)用手套.第1部分:孔自由度試驗(yàn)和要求 |
Medical gloves for single use - Part 1 : requirements and testing for freedom from holes. |
| NF S97-0011-1998 |
NF S 97-001 的補(bǔ)充件1 |
() |
| NF S97-002 1-1998 |
NF S 97-002的補(bǔ)充件1 |
|
| NF S97-002-2001 |
一次性醫(yī)療手套.第2部分:物理性能的要求和檢驗(yàn)方法 |
Medical gloves for single use - Part 2 : requirements and testing for physical properties. |
| NF S97-0021-1998 |
NF S 97-002的補(bǔ)充件1 |
() |
| NF S97-003-2000 |
一次性醫(yī)用手套.第3部分:生物評(píng)估的要求和試驗(yàn)方法 |
Medical gloves for single use - Part 3 : requirements and testing for biological evaluation. |
| NF S97-032-2002 |
銅支承的宮內(nèi)節(jié)育避孕器具.要求、試驗(yàn) |
Copper-bearing intra-uterine contraceptive devices - Requirements, tests. |
| NF S97-034-1998 |
添加潤(rùn)滑劑和醫(yī)用或非醫(yī)用的制劑,放在與避孕套接觸的部位.相容性.規(guī)范和試驗(yàn)方法 |
ADDITIONAL LUBRICANTS AND MEDICINAL OR NON-MEDICINAL PREPARATIONS INTENDED OR LIKELY TO BE PLACED IN CONTACT WITH MALE CONDOMS. COMPATIBILITY. SPECIFICATIONS AND TEST METHODS. |
| NF S97-036-2002 |
天然乳膠橡膠陰莖套.要求和試驗(yàn)方法 |
Natural latex rubber condoms - Requirements and test methods. |
| NF S97-045-2002 |
臨床試驗(yàn)用橡膠陰莖套.物理性能的測(cè)量 |
Rubber condoms for clinical trials - Measurement of physical properties. |
| NF S97-101-1996 |
無(wú)侵入血壓計(jì).第1部分:一般要求 |
Non-invasive sphygmomanometers. Part 1 : general requirements. |
| NF S97-101/A1-2002 |
非侵入式血壓計(jì).第1部分:一般要求 |
Non-invasive sphygmomanometers - Part 1 : general requirements. |
| NF S97-102-1996 |
無(wú)侵入血壓計(jì).第2部分:機(jī)械血壓計(jì)的補(bǔ)充要求 |
Non-invasive sphygmonanometers - Part 2 : supplementary requirements for mechanical sphygmomanometers. |
| NF S97-121-1-1997 |
醫(yī)用非織造敷布的試驗(yàn)方法.第1部分:敷布生產(chǎn)用非紡織品(歐洲標(biāo)準(zhǔn)EN 1644-1) |
TEST METHODS FOR NONWOVEN COMPRESSES FOR MEDICAL USE. PART 1 : NONWOVENS USED IN THE MANUFACTURE OF COMPRESSES. (EUROPEAN STANDARD EN 1644-1). |
| NF S97-121-2-2000 |
醫(yī)用非織造敷布的試驗(yàn)方法.第2部分:成品敷布 |
Test methods for nonwoven compresses for medical use - Part 2 : finished compresses. |
| NF S97-122-1-2002 |
主要傷口敷料試驗(yàn)方法.第1部分:吸收度 |
Test methods for primary wound dressings - Part 1 : aspects of absorbency. |
| NF S97-122-2-2002 |
主要傷口敷料試驗(yàn)方法.第2部分:可滲透薄膜敷料濕氣蒸發(fā)傳輸率 |
Test methods for primary wound dressings - Part 2 : moisture vapour transmission rate of permeable film dressings. |
| NF S97-122-3-2003 |
非放射性醫(yī)療器械.主要傷口敷料試驗(yàn)方法.第3部分:防水性 |
(Non-active medical devices - Test methods for primary wound dressings - Part 3 : waterproofness.) |
| NF S97-122-4-2003 |
非放射性醫(yī)療器械.主要傷口敷料試驗(yàn)方法.第4部:合格性 |
(Non-active medical devices - Test methods for primary wound dressings - Part 4 : conformability.) |
| NF S97-122-6-2003 |
非放射性醫(yī)療器械.主要傷口敷料試驗(yàn)方法.第6部分:氣味控制 |
(Non-active medical devices - Test methods for primary wound dressings - Part 6 : odour control.) |
| NF S97-132-2003 |
光學(xué)和光學(xué)儀器.激光和激光相關(guān)設(shè)備.手術(shù)單和/或病人保護(hù)罩耐激光性的試驗(yàn)方法 |
(Optics and optical instruments - Lasers and laser-related equipment - test method for the laser-resistance of surgical drapes and/or patient-protective covers.) |
| NF S97-150-1-2000 |
體溫計(jì).第1部分:最大設(shè)計(jì)金屬玻管液體溫度計(jì) |
(Clinical thermometers - Part 1 : metallic liquid-in-glass thermometers with maximum device.) |
| NF S97-150-2-2000 |
體溫計(jì).第2部分:相變型(點(diǎn)矩陣)溫度計(jì) |
(Clinical thermometers - Part 2 : phase change-type (dot matrix) thermometers.) |
| NF S97-150-3-2000 |
體溫計(jì).第3部分:最大設(shè)計(jì)(不預(yù)示和預(yù)示)袖珍電溫度計(jì)的性能 |
(Clinical thermometers - Part 3 : performance of compact electrical thermometers (non-predictive and predictive) with maximum device.) |
| NF S97-150-4-2000 |
體溫計(jì).第4部分:連續(xù)測(cè)量電溫度計(jì)的性能 |
(Clinical thermometers - Part 4 : performance of electrical thermometers for continuous measurement.) |
| NF S97-150-5-2003 |
體溫計(jì).第5部分:(大刻度的)耳蝸式紅外測(cè)溫計(jì)的性能 |
(Clinical thermometers - Part 5 : performance of infra-red ear thermometers (with maximum device).) |
| NF S97-165-1-2003 |
病人、醫(yī)務(wù)人員和醫(yī)療設(shè)備做為醫(yī)療用品使用的手術(shù)蓋單、長(zhǎng)外衣、無(wú)污染套裝.制造商、加工者及產(chǎn)品的一般要 |
(Surgical drapes, growns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Part 1 : general requirements for manufacturers, processors and products.) |
| NF S97-317-1998 |
支持醫(yī)用設(shè)備的軌道系統(tǒng)(歐洲標(biāo)準(zhǔn) EN 12218) |
(Rail systems for supporting medical equipment.) |
| NF S97-317/A1-2002 |
支承醫(yī)療設(shè)備的支架系統(tǒng) |
(Rail systems for supporting medical equipment.) |
| NF S97-500-2003 |
醫(yī)療信息學(xué).醫(yī)用分析儀與實(shí)驗(yàn)室信息系統(tǒng)的接口.使用說(shuō)明文件 |
(Health informatics - Clinical analyser interfaces to laboratory information systems - Use profiles.) |
| NF S97-530-2002 |
醫(yī)療信息學(xué).有關(guān)輸血的信息.通訊和數(shù)據(jù)模型 |
Medical informatics - Messages concerning blood transfusion - Communication and data model. |
| NF S97-531-2002 |
醫(yī)療信息學(xué).有關(guān)輸血的信息.指定的供血信息和指定的供血信息報(bào)告 |
Medical informatics - Messages concerning blood transfusion - Nominative delivery message and report on nominative delivery message. |
| NF S97-532-2002 |
醫(yī)療信息學(xué).有關(guān)輸血的信息.易變血液產(chǎn)品供給信息 |
Medical informatics - Messages concerning blood transfusion - Labile blood product delivery message. |
| NF S97-543-1998 |
護(hù)理信息學(xué).聯(lián)合國(guó)標(biāo)準(zhǔn)化信息.醫(yī)療設(shè)備的成本和使用 |
HEALTHCARE INFORMATICS. UNITED NATIONS STANDARDIZED MESSAGE. COST AND IMPLEMENTATION OF MEDICAL RESSOURCES (MEDRUC). |
| NF S97-559-2002 |
醫(yī)學(xué)信息.外科手術(shù)的分類和編碼系統(tǒng)用目錄結(jié)構(gòu) |
Health informatics - Categorial structure for classifications and coding systems of surgical procedures. |
| NF S97-601-1-2000 |
醫(yī)療設(shè)備制造用動(dòng)物組織及其衍生物.第1部分:風(fēng)險(xiǎn)分析和管理 |
Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 1 : analysis and management of risk. |
| NF S97-601-2-2000 |
醫(yī)療設(shè)備制造用動(dòng)物組織及其衍生物.第2部分:資源控制、采集和輸送 |
Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 2 : controls on sourcing, collection and handling. |
| NF S97-601-3-2000 |
醫(yī)療設(shè)備制造用動(dòng)物組織及其衍生物.第3部分:病毒和其它傳染劑的清除和/或僵化的證實(shí) |
Animal tissues et their derivatives utilized in the manufacture of medical devices - Part 3 : validation of the elimination and/or inactivation of viruses and other transmissible agents. |
| NF S98-001-1997 |
消毒器用非生物系統(tǒng).第1部分:一般要求 |
NON-BIOLOGICAL SYSTEMS FOR USE IN STERILIZER. PART 1 : GENERAL REQUIREMENTS. (EUROPEAN STANDARD EN 867-1). |
| NF S98-002-1997 |
消毒器用非生物系統(tǒng).第2部分:處理指示器(A類) |
NON-BIOLOGICAL SYSTEMS FOR USE IN STERILIZERS. PART 2 : PROCESS INDICATORS (CLASS A). (EUROPEAN STANDARD EN 867-2). |
| NF S98-003-1997 |
消毒器用非生物系統(tǒng).第3部分:BOWIE和二氯乙胂試驗(yàn)中用的B類指示器規(guī)范 |
NON-BIOLOGICAL SYSTEMS FOR USE IN STERILIZERS. PART 3 : SPECIFICATION FOR CLASS B INDICATORS FOR USE IN THE BOWIE AND DICK TEST. (EUROPEAN STANDARD EN 867-3). |
| NF S98-004-1-1997 |
消毒器試驗(yàn)和消毒過(guò)程用生物系統(tǒng).第1部分:一般要求 |
Biological systems for testing sterilizers and sterilization processes. Part 1 : general requirements. |
| NF S98-004-2-1997 |
消毒器試驗(yàn)和消毒過(guò)程用生物系統(tǒng).第2部分:環(huán)氧乙烷消毒器用特殊系統(tǒng) |
Biological systems for testing sterilizers and sterilization processes. Part 2 : particular systems for use in ethylene oxide sterilizers. |
| NF S98-004-3-1997 |
消毒器試驗(yàn)和消毒過(guò)程用生物系統(tǒng).第3部分:濕熱消毒器用特殊系統(tǒng) |
Biological systems for testing sterilizers and sterilization processes. Part 3 : particular systems for use in moist heat sterilizers. |
| NF S98-004-4-2000 |
消毒器試驗(yàn)和消毒方法用生物學(xué)系統(tǒng).第4部分:輻射消毒器用專門系統(tǒng) |
Biological systems for testing sterilizers and sterilization processes - Part 4 : particular systems for use in irradiation sterilizers. |
| NF S98-004-5-2000 |
消毒器試驗(yàn)和消毒方法用生物學(xué)系統(tǒng).第5部分:低溫蒸汽和甲醛消毒器用專門系統(tǒng) |
Biological systems for testing sterilizers and sterilization processes - Part 5 : particular systems for use in low temperature steam and formaldehyde sterilizers. |
| NF S98-004-6-2000 |
消毒器試驗(yàn)和消毒方法用生物學(xué)系統(tǒng).第6部分:干熱消毒器用專門系統(tǒng) |
Biological systems for testing sterilizers and sterilization processes - Part 6 : particular systems for use in dry heat sterilizers. |
| NF S98-004-7-2000 |
消毒器試驗(yàn)和消毒方法用生物學(xué)系統(tǒng).第7部分:濕熱消毒器用自帶生物指示劑系統(tǒng)的特殊要求 |
Biological systems for testing sterilizers and sterilization processes - Part 7 : particular requirements for self-contained biological indicator systems for use in moist heat sterilizers. |
| NF S98-004-8-2000 |
消毒器試驗(yàn)和消毒方法用生物學(xué)系統(tǒng).第8部分:環(huán)氧乙烷消毒器用的配套的生物指示器系統(tǒng)的特殊要求 |
Biological systems for testing sterilizers and sterilization processes - Part 8 : particular requirements for self-contained biological indicator systems for use in ethylene oxide sterilizers. |
| NF S98-006-2001 |
消毒器用非生物系統(tǒng).第4部分:蒸汽探傷檢驗(yàn)的Bowie 和Dick試驗(yàn)指示物可選擇替代的規(guī)范 |
Non-biological systems for use in sterilizers - Part 4 : specification for indicators as an alternative to the Bowie and Dick test for the detection of steam penetration. |
| NF S98-007-2001 |
消毒器用非生物系統(tǒng).第5部分:B型和S型小型消毒器的指示器系統(tǒng)和加工置換設(shè)備 |
Non-biological systems for use in sterilizers - Part 5 : specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S. |
| NF S98-011-1997 |
清毒.蒸汽消毒器.大型消毒器(EN 285) |
Sterilization. Steam sterilizers. Large sterilizers. |
| NF S98-012-2003 |
醫(yī)用滅菌器.低溫蒸汽和甲醛滅菌器.要求和試驗(yàn) |
(Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing.) |
| NF S98-015-1997 |
醫(yī)用消毒器.環(huán)氧乙烷消毒器.要求和試驗(yàn)方法 |
Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods. |
| NF S98-051-1997 |
已消毒醫(yī)療設(shè)備用包裝材料和系統(tǒng).第1部分:一般要求和試驗(yàn)方法 |
Packaging materials and systems for medical devices which are to be sterilized. Part 1 : general requirements and test methods. |
| NF S98-051-2-1999 |
已消毒醫(yī)療設(shè)備用包裝材料和系統(tǒng).第2部分:消毒的包裹物.要求和試驗(yàn)方法 |
PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED. PART 2 : STERILIZATION WRAP. REQUIREMENTS AND TEST METHODS. (EUROPEAN STANDARD EN 868-2). |
| NF S98-051-3-1999 |
要消毒的醫(yī)療設(shè)備用包裝材料和系統(tǒng).第3部分:小袋和卷軸生產(chǎn)及紙袋生產(chǎn)用紙.要求和試驗(yàn)方法 |
|
| NF S98-051-4-1999 |
要消毒的醫(yī)療設(shè)備用包裝材料和系統(tǒng).第4部分:要求和試驗(yàn)方法 |
PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED. PART 4 : PAPER BAGS. REQUIREMENTS AND TEST METHODS. (EUROPEAN STANDARD EN 868-4). |
| NF S98-051-5-1999 |
要消毒的醫(yī)療設(shè)備用包裝材料和系統(tǒng).第5部分:加熱封閉和可自封閉的紙及塑料薄膜結(jié)構(gòu)的袋和卷軸.要求和試驗(yàn)方法 |
Packaging materials and systems for medical devices which are to be sterilized - Part 5 : heat and self-sealable pouches and reels of paper and plastic film construction - Requirements and test methods. |
| NF S98-051-6-1999 |
要消毒的醫(yī)療設(shè)備用包裝材料和系統(tǒng).第6部分:醫(yī)療上用環(huán)氧乙烷或輻照消毒用紙袋的生產(chǎn)用紙.要求和試驗(yàn)方法. |
PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED. PART 6 : PAPER FOR THE MANUFACTURE OF PACKS FOR MEDICAL USE FOR STERILIZATION BY ETHYLENE OXIDE OR IRRADIATION. REQUIREMENTS AND TEST METHODS. (EUROPEAN STANDARD EN 868-6). |
| NF S98-051-7-1999 |
要消毒的醫(yī)療設(shè)備用包裝材料和系統(tǒng).第7部分:醫(yī)療上用環(huán)氧乙烷或輻照消毒用熱封閉袋的生產(chǎn)用粘貼涂覆紙.要求和試驗(yàn)方法. |
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| NF S98-051-8-1999 |
要消毒的醫(yī)療設(shè)備用包裝材料和系統(tǒng).第8部分:與EN285一致的蒸氣消毒器用可再使用的消毒容器.要求和試驗(yàn)方法 |
Packaging materials and systems for medical devices which are to be sterilized. Part 8 : re-usable sterilization containers for steam sterilizers conforming to EN 285. Requirements and test methods. |
| NF S98-059-2000 |
要消毒的醫(yī)療設(shè)備用包裝材料和系統(tǒng).第9部分:加熱密封袋、卷軸和蓋用未涂覆非織造聚烯烴材料.要求和試驗(yàn)方法 |
Packaging materials and systems for medical devices which are to be sterilized - Part 9 : uncoated nonwoven materials of polyolefines for use in the manufacture of heat sealable pouches, reels and lids - Requirements and test methods. |
| NF S98-060-2000 |
要消毒的醫(yī)療設(shè)備用包裝材料和系統(tǒng).第10部分:加熱密封袋、卷軸和蓋用膠粘涂覆非織造聚烯烴材料.要求和試驗(yàn)方法 |
Packaging materials and systems for medical devices which are to be sterilized - Part 10 : adhesive coated nonwoven materials of polyolefines for use in the manufacture of heat sealable pouches, reels and lids - Requirements and test methods. |
| NF S98-100-2002 |
醫(yī)療保健產(chǎn)品的消毒.生物指示器.結(jié)果的選擇、使用和解釋的指南 |
Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results. |
| NF S98-101-1994 |
醫(yī)療器械的殺菌.環(huán)氧乙烷殺菌的確認(rèn)和常規(guī)控制方法.要求 |
STERILIZATION OF MEDICAL DEVICES. VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION. (EUROPEAN STANDARD EN 550). |
| NF S98-103 1-1999 |
NF S98-103-94的補(bǔ)充件1 |
|
| NF S98-103-1994 |
醫(yī)療器械的殺菌.輻射殺菌的確認(rèn)和常規(guī)控制方法.要求(EN 552) |
STERILIZATION OF MEDICAL DEVICES. VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION. (EUROPEAN STANDARD EN 552). |
| NF S98-103/A2-2001 |
醫(yī)療裝置的消毒.通過(guò)輻射對(duì)消毒的常規(guī)控制和檢驗(yàn) |
Sterilization of medical devices - Validation and routine control of sterilization by irradiation. |
| NF S98-1031-1999 |
NF S98-103-94的補(bǔ)充件1 |
() |
| NF S98-105-1994 |
醫(yī)療器械的殺菌.蒸汽殺菌的確認(rèn)和常規(guī)控制方法 |
STERILIZATION OF MEDICAL DEVICES. VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT. (EUROPEAN STANDARD EN 554). |
| NF S98-107-1-2002 |
醫(yī)療器械的消毒.對(duì)被標(biāo)記消毒的醫(yī)療器械的要求.第1部分:對(duì)經(jīng)終端消毒的醫(yī)療器械的要求 |
Sterilization of medical devices - Requirements for medical devices to be designated STERILE - Part 1 : requirements for terminally sterilized medical devices. |
| NF S98-108-1996 |
醫(yī)學(xué)產(chǎn)品的消毒,一件產(chǎn)品上微生物種群的估計(jì).第1部分:要求 |
Sterilization of medical devices. Estimation of the population of micro-organisms on product. Part 1 : requirements. |
| NF S98-109-2-1997 |
醫(yī)療器械的殺菌.微生物菌群制品的確認(rèn).第2部分:導(dǎo)則 |
Sterilization of medical devices. Estimation of the population of micro-organisms on product. Part 2 : guidance. |
| NF S98-110-3-1997 |
醫(yī)療器械的殺菌.微生物菌群制品的確認(rèn).第3部分:微生物技術(shù)批準(zhǔn)方法導(dǎo)則 |
Sterilization of medical devices. Estimation of the population of micro-organisms on product. Part 3 : guide to the methods for validation of microbiological techniques. |
| NF S98-112-1998 |
液體化學(xué)消毒液消毒的確認(rèn)和常規(guī)控制方法.一次性醫(yī)用設(shè)備混合動(dòng)物源材料的消毒 |
Validation and routine control of sterilization by liquid chemical sterilants. Sterilization of single-use medical devices incorporating materials of animal origin. |
| NF S98-115-2001 |
保健產(chǎn)品的消毒.醫(yī)療設(shè)備消毒方法的制定、確認(rèn)和常規(guī)控制及消毒劑特性的通用標(biāo)準(zhǔn) |
Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilizing process for medical devices. |
| NF S98-118-2-2000 |
醫(yī)療設(shè)備的消毒.微生物法.第2部分:消毒過(guò)程鑒定所做的無(wú)菌實(shí)驗(yàn) |
Sterilisation of medical devices - Microbiological methods - Part 2 : tests of sterility performed in the validation of a sterilization process. |
| NF S99-003-1998 |
制造商提供的醫(yī)療裝置信息 |
Information supplied by the manufacturer with medical devices. |
| NF S99-004-1996 |
醫(yī)療裝置標(biāo)簽中使用的圖形符號(hào) |
Graphical symbols for use in the labelling of medical devices. |
| NF S99-004/A1-1999 |
醫(yī)療器械標(biāo)簽用圖形符號(hào) |
Graphical symbols for use in the labelling of medical devices. |
| NF S99-012-2000 |
命名法.規(guī)定數(shù)據(jù)交換用醫(yī)療設(shè)備命名系統(tǒng)規(guī)范 |
Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange. |
| NF S99-101-2001 |
質(zhì)量系統(tǒng).醫(yī)療設(shè)備.EN ISO 9001應(yīng)用的特殊要求 |
Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001. |
| NF S99-102-1996 |
質(zhì)量體系.醫(yī)療設(shè)備.EN ISO 9002使用的特殊要求(歐洲標(biāo)準(zhǔn)EN 46002) |
Quality systems. Medical devices. Particular requirements for the application of EN ISO 9002. |
| NF S99-110-1995 |
非放射性醫(yī)療器械用EN 29001、EN 46001、EN 29002和EN 46002的應(yīng)用導(dǎo)則 |
Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for non-active medical devices. |
| NF S99-172-2003 |
醫(yī)療設(shè)備的使用.與保健人員對(duì)醫(yī)療設(shè)備的使用相關(guān)的風(fēng)險(xiǎn)管理 |
(Use of medical devices - Risk management relative to the use of medical devices in health care establishments.) |
| NF S99-201-1-2003 |
人用醫(yī)療設(shè)備的臨床調(diào)查.第1部分:一般要求 |
(Clinical investigation of medical devices for human subjects - Part 1 : general requirements.) |
| NF S99-201-1993 |
人用醫(yī)療器械的臨床研究 |
Clinical investigation of medical devices for human subjects. |
| NF S99-201-2-2003 |
醫(yī)學(xué)受驗(yàn)者用醫(yī)療器械的臨床調(diào)查.第2部分:臨床調(diào)查計(jì)劃 |
(Clinical investigation of medical devices for human subjects - Part 2 : Clinical investigation plans.) |
| NF S99-211-2001 |
醫(yī)療裝置.醫(yī)療裝置風(fēng)險(xiǎn)管理應(yīng)用 |
Medical devices - Application of risk management to medical devices. |
| NF S99-301-1995 |
醫(yī)療設(shè)備.電報(bào)警信號(hào) |
Medical devices. Electrically generated alarm signals. |
| NF S99-401-1994 |
衛(wèi)生器材.醫(yī)學(xué)級(jí)的硅彈性體 |
MEDICAL DEVICES. SILICONE ELASTOMETER OF MEDICAL GRADE. |
| NF S99-501-1998 |
生物學(xué)評(píng)估和醫(yī)療裝置.評(píng)估和試驗(yàn) |
Biological evaluation of medical devices. Part 1 : evaluation and testing. |
| NF S99-502-1998 |
醫(yī)療裝置的生物評(píng)定.第2部分:動(dòng)物平安要求 |
Biological evaluation of medical devices. Part 2 : animal welfare requirements. |
| NF S99-503-1994 |
醫(yī)療裝置生物學(xué)評(píng)定.第503部分:遺傳毒性、致癌力和生殖毒性試驗(yàn) |
Biological evaluation of medical devices. Part 3 : tests for genotoxicity, carcinogenicity and reproductive toxicity. |
| NF S99-504-1994 |
醫(yī)療裝置生物學(xué)評(píng)定.第4部分:與血液相互作用試驗(yàn)選擇 |
Biological evaluation of medical devices. Part 4 : selection of tests for interactions with blood. |
| NF S99-505-5-1999 |
醫(yī)療器械的生物評(píng)定.第5部分:細(xì)胞毒性試驗(yàn).玻璃試管法 |
Biological evaluation of medical devices - Part 5 : tests for in vitro cytotoxicity. |
| NF S99-506-1995 |
醫(yī)療裝置生物學(xué)評(píng)定.第6部分:植入后局部作用試驗(yàn) |
Biological evaluation of medical devices. Part 6 : tests for local effects after implantation. |
| NF S99-507-1996 |
醫(yī)療裝置生物學(xué)評(píng)定.第7部分:環(huán)氧乙烷消毒殘余物 |
Biological evaluation of medical devices. Part 7 : ethylene oxide sterilization residuals. |
| NF S99-508-2001 |
醫(yī)療器械的生物評(píng)定.第8部分:生物試驗(yàn)用參考材料的選擇和合格證明 |
Biological evaluation of medical devices - Part 8 : selection and qualification of reference materials for biological tests. |
| NF S99-509-1999 |
醫(yī)療裝置的生物評(píng)定.第9部分:潛在降解產(chǎn)品鑒定和量化框架 |
Biological evaluation of medical devices. Part 9 : framework for identification and quantification of potential degradation products. |
| NF S99-510-2003 |
醫(yī)療器械的生物評(píng)定.第10部分:刺激與持續(xù)型過(guò)敏癥試驗(yàn) |
Biological evaluation of medical devices - Part 10 : tests for irritation and delayed-type hypersensitivity. |
| NF S99-511-1996 |
醫(yī)療裝置的生物評(píng)定.第11部分:系統(tǒng)毒性試驗(yàn) |
Biological evaluation of medical devices. Part 11 : tests for systemic toxicity. |
| NF S99-512-1997 |
醫(yī)療器械的生物評(píng)定.第12部分:樣品制備和參考材料 |
Plastics. Phenolic resins. Definitions and test methods. |
| NF S99-513-1999 |
醫(yī)療器械的生物評(píng)定.第13部分:聚合醫(yī)療器械中老化產(chǎn)品的識(shí)別與量化 |
Biological evaluation of medical devices. Part 13 : identification and quantification of degradation products from polymeric medical devices. |
| NF S99-514-2002 |
醫(yī)療器械的生物評(píng)定.第14部分:陶瓷降解產(chǎn)品的識(shí)別與合格鑒定 |
Biological evaluation of medical devices - Part 14 : identification and quantification of degradation products from ceramics. |
| NF S99-515-2001 |
醫(yī)療器械的生物評(píng)定.第15部分:對(duì)從金屬和合金中降解的產(chǎn)品的識(shí)別和合格檢驗(yàn) |
Biological evaluation of medical devices - Part 15 : identification and quantification of degradation products from metals and alloys. |
| NF S99-516-1997 |
醫(yī)療裝置的生物評(píng)定.第16部分:降解產(chǎn)品和可濾清物的毒理動(dòng)力學(xué)研究設(shè)計(jì)方法 |
Biological evaluation of medical devices. Part 16 : toxicokinetic study design for degradation products and leachables. |
| NF S99-517-2003 |
醫(yī)療器械的生物評(píng)定.第17部分:可慮取物質(zhì)容許限值的確定 |
(Biological evaluation of medical devices - Part 17 : establishment of allowable limits for leachable substances.) |
| NF T01-001-1962 |
化工.素名稱和符號(hào).原子量表 |
CHEMICAL INDUSTRIES. NAMES AND SYMBOLS OF ELEMENTS. TABLE OF RELATIVE ATOMIC WEIGHTS. |
| NF T01-002-1980 |
化工.化學(xué)分析方法的標(biāo)準(zhǔn)流程圖 |
Chemical industry. Layout for a standard method of chemical analysis. |
| NF T01-003-1965 |
化工.無(wú)機(jī)化學(xué)術(shù)語(yǔ) |
CHEMICAL INDUSTRIES. INORGANIC CHEMISTRY NOMENCLATURE. |
| NF T01-004-1968 |
化工.氣相色譜法.術(shù)語(yǔ)和符號(hào) |
CHEMICAL INDUSTRIES. GAS CHROMATOGRAPHY. TERMS AND SYMBOLS. |
| NF T01-005-1969 |
化工.氣相色譜法.化學(xué)分析方法的標(biāo)準(zhǔn)流程圖 |
Chemical industries. Standard layout for methods of chemical analysis by gas chromatography. |
| NF T01-010-1964 |
化工.實(shí)驗(yàn)室用高氯酸的注意事項(xiàng) |
CHEMICAL INDUSTRIES. PRECAUTIONS CONCERNING THE USE OF PERCHLORIC ACID IN LABORATORIES. |
| NF T01-011-1970 |
pH值指示劑.優(yōu)選溶液表 |
PH INDICATORS,SCHEDULE OF PREFERRED CHEMICAL INDICATORS. |
| NF T01-012-1973 |
pH計(jì).PH計(jì)校準(zhǔn)用標(biāo)準(zhǔn)溶液 |
PH-MEASUREMENT-STANDARD SOLUTIONS FOR CALIBRATION OF PH-METERS. |
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