Make your own free website on Tripod.com

       首頁 向上                    

    中華民國中歐產業研究學會

 

 

 

 

您若有任何問題請與我們聯絡, 我們將在24小時之內給您回覆

                          本會所蒐集的EN/IEC 國際標準
EN 71-1~-6 Mechanical & Physical Properties for Toy Test
EN 165 Personal eye-protection-Vocabulary
EN 166 Personal eye- protection Specifications
EN 167 Personal eye- protection Optical test methods
EN 168 Personal eye- protection -Non-optical test methods
EN 171 Specification for infra-red filters used in personal eye-protection equipment
EN 172 Sun glare filters used inn personal eye-protectors for industrial use
EN 200 Sanitary tap ware: General technical specifications fro single taps and mixer taps
EN 285 Sterilization--- Steam sterilizers Large sterilizers
EN 292-1 Safety of machinery- Basic concepts, general principles for design Part 1 : basic terminology, methodology
EN 292-2 Safety of machinery- Basic concepts, general principles for design Part 2 : Technical principles and specifications
EN 294 Safety of machinery--Safety distances to prevent danger zones being reached by the upper limbs
EN 375 Information supplied by the manufacturer with in vitro diagnostic reagents for professional use
EN 376_1992 Specification for  Labeling of in vitro diagnostic reagents for self-testing
EN 376_2002 Specification for  Labeling of in vitro diagnostic reagents for self-testing
EN 414 Safety of machinery Rules for the drafting and presentation of safety standards
EN455-1 Medical gloves for single use Part 1 : specification for freedom from holes
EN455-2 Medical gloves for single use Part 2 : specification for physical properties
Pr EN455-3 Medical gloves for single use Part 3 : Requirements and testing for biological evaluation
EN 455-3 Medical gloves for single use Part 3 : Requirements and testing for biological evaluation
EN 540 Clinical investigation of medical devices for human subjects
EN 550 Sterilization of medical devices Validation and routine control of ethylene oxide sterilization
EN 552 Sterilization of medical devices Validation and routine control of sterilization by irradiation
EN 554 Sterilization of medical devices Validation and routine control of sterilization by moist heat
EN 556 Sterilization of medical devices Validation and routine control of ethylene oxide sterilization
EN 556-1 Sterilization of medical devices -- Requirements for medical devices to be designated "STERILE''     Part 1: Requirements for terminally sterilized medical devices
EN 591 Instructions for use for in vitro diagnostic instruments for professional use
EN 592 Specification for User manuals for in vitro diagnostic instruments for home use
EN 598 Ductile iron pipes, fittings, accessories and their joints for sewerage applications-- requirements and test methods
EN 724 application of EN29001 and EN 46001 and of EN29002 and EN46002 for non-active medical devices
EN 865 Pulse oximeters-- Particular requirements
EN 866-1 Biological systems for testing sterilizers and sterilization processes Part 1: general requirements
EN 866-2 Biological systems for testing sterilizers and sterilization processes Part 2: Particular systems for use in ethylene oxide sterilizers
EN 866-3 Biological systems for testing sterilizers and sterilization processes Part 3: Particular systems for use in moist heat sterilizers
EN 867-1 Non-biological systems for use in sterilizers Part 1: General requirements
EN 867-2 Non-biological systems for use in sterilizers Part 2: Process indicators (Class A)
EN 867-3 Non-biological systems for use in sterilizers Part 3: Specification for Class B indicators for use in the Bowie and Dick test
EN 868-1 Packaging materials and systems for medical devices which are to be sterilized-- Part 1: general requirements and test methods
EN 954-1 Safety of machines Safety-related parts of control systems Part 1: General principles for design
EN 957-1 Stationary training equipment  Part 1: general safety requirements and test methods
EN 957-2 Stationary training equipment  Part 2: Strength training equipment---- Additional specific safety requirements and test methods
EN 957-4 Stationary training equipment  Part 4: Strength training benches----Additional specific safety requirements and test methods
EN 957-5 Stationary training equipment  Part 5: Pedal crank training equipment---- Additional specific safety requirements and test methods
EN 957-6 Stationary training equipment  Part 6: Treadmills---- Additional specific safety requirements and test methods
EN 957-7 Stationary training equipment  Part 7: Rowing machines--- Additional specific safety requirements and test methods
EN 957-8 Stationary training equipment  Part 8: Steppers, stair climbers  and climbers--- Additional specific safety requirements and test methods
EN 980_2003 Graphical symbols for use in the labeling of medical devices
EN 980_2008 Graphical symbols for use in the labeling of medical devices
EN 982 Safety of machines Safety-requirements for fluid power systems and their components Hydraulics
EN 983 Safety of machines Safety requirements for fluid power systems and their components Pneumatics
pr EN 1041 Draft Information supplied by the manufacturer with medical devices
EN1041 Information supplied by the manufacturer with medical devices
EN 1050 Safety of machines Principles for risk assessment
EN 1060-1 Non-invasive sphygmomanometers ( blood pressure meter) Part 1. General requirements
EN 1060-2 Non-invasive sphygmomanometers Part 2. Supplementary requirements for mechanical sphygmomanometers
EN 1060-3 Non-invasive sphygmomanometers Part 3. Supplementary requirements for electro-mechanical blood pressure measuring systems
EN 1174-1 Sterilization of medical devices-- Estimation of the population of micro-organisms on product Part 1. Requirements
EN 1174-2 Sterilization of medical devices--Estimation of the population of micro-organisms on product Part 2. Guidance
EN 1174-3 Sterilization of medical devices-- Estimation of the population of micro-organisms on product Part 3. Guide to the methods for validation of microbiological techniques
pr EN 1441 Draft of Medical devices-- Risk analysis
EN 1441 Medical devices-- Risk analysis
EN 1639 Dentistry   Medical devices for dentistry-- Instruments
EN 1970_2000 Adjustable beds for disabled persons-- Requirements and test methods
EN 10021 General technical --Delivery requirements for steel and iron products
EN 10088-1 Stainless steels Part 1: List of stainless steels
EN 10088-2 Stainless steels Part 2: Technical delivery conditions for sheet/ plate and strip for general purposes
EN 10088-3 Stainless steels Part 3: Technical delivery conditions for semi-finished products, bars, rods and sections for general purposes
EN 10204 Metallic products-- Types of inspection documents
EN ISO 10535_2006 Hoists for the transfer of disabled persons -- requirements and methods
EN 12075 Biotechnology-Large scale process and production-- Procedures for fermentation and downstream processes 
EN 12181 Oropharyngeal airways
EN 12182 Technical aids for disabled persons -- General requirements and test methods
EN 12183 Manually propelled wheelchairs Requirement and test methods
EN 12184 Electrically powered wheelchairs, scoots and their chargers-- Requirements and test methods
prEN 12470-1 Clinical thermometers Part 1: Metallic liquid-in-glass thermometers with maximum device
EN 12470-1 Clinical thermometers Part 1: Metallic liquid-in-glass thermometers with maximum device
prEN 12470-2 Clinical thermometers Part 2: Phase change-type (dot matrix) thermometers
EN 12470-2 Clinical thermometers Part 2: Phase change-type (dot matrix) thermometers
prEN 12470-3 Clinical thermometers Part 3: Compact electrical thermometers (non-predictive and predictive) with maximum device
EN 12470-3 Clinical thermometers Part 3: Compact electrical thermometers (non-predictive and predictive) with maximum device
EN 12470-4 Clinical thermometers Part 4: Performance of electrical thermometers for continuous measurement
EN 12470-5 Clinical thermometers Part 5: Performance of infra-red ear thermometers (with maximum device)
prEN 13060-1 Small steam sterilizers-Part 1:General requirements for all types of small steam sterilizers
prEN 13328-2 Breathing system filters for anesthetic and respiratory use-  Part 2: Non-filtration aspects
EN 13532  General requirements for in vitro diagnostic medical devices for self-testing
EN 13544-1 Respiratory therapy equipment   Part 1: Nebulizing systems and their components
EN 13612 Performance evaluation of in vitro diagnostic medical devices
EN 13640 Stability testing of in vitro diagnostic reagents
EN 13641 Elimination or reduction of risk of infection related to in vitro diagnostic reagents
EN 13794 Respiratory protective devices - Self-contained closed-circuit breathing apparatus for escape
EN 14079 Non-active medical devices-Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze
EN 14683 Surgical masks - Requirements and test methods
EN ISO 14971_2012 Medical devices---Application of risk management to medical devices
EN ISO 15223_2012 Medical devices-- Symbols to be used with medical device labels, labeling and information to be supplied
BS EN 10555-1_2009 Sterile, single use Intravascular Catheters; Part 1: General requirements
EN 20594-1 (AMD 9881) Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment Part 1: general requirements
EN 23964 Dental handpieces and accessories-- Part 2: Accessories-  Section 2.2 Specification for coupling dimensions
EN 30993-1 Biological evaluation of medical devices Part 1: guidance on selection of tests
EN 30993-6 Biological evaluation of medical devices Part 6: Tests for local effects after implantation
EN 45014 General criteria for supplier's declaration of conformity
EN 45020 Glossary of terms for Standardization and related activities
EN 46001 Specification for Application of EN29001 (BS 5750: Part 1) to the manufacture of medical devices
EN 50081-1 Electromagnetic compatibility--- Generic emission standard Part 1: Residential, commercial and light industry
EN 50081-2 Electromagnetic compatibility--- Generic emission standard Part 2: Industrial environment
prEN 50099-1 Safety of machines Indication, marking and actuation Part 1:requirements for visual, auditory and castile signals
EN 60118-1 Hearing Aids--Part 1: Hearing aids with induction pick-up coil input
EN 60118-13 Hearing Aids--Part 13: Electromagnetic compatibility (EMC)--Product standard
EN 60204 Safety of machines Electrical equipment of machines Part 1:General requirements
EN 60335-1 Safety of household and similar electrical appliances Part 1:General requirements
EN 60601-1_2007 Medical electrical equipment Part 1: General requirements for safety
EN 60601-1-3 Medical electrical equipment Part 1: General requirements for safety Section 1.3 Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment
EN 60601-1-4 Medical electrical equipment Part 1: General requirements for safety Section 1.4 Collateral standard: Programmable electrical medical systems
EN 60601-2-28_1993 Medical electrical equipment Part 1: General requirements for safety Section 2.128 Specification for X-ray source assemblies and X-ray tube assemblies for medical diagnosis
EN 60601-2-32_1994 Medical electrical equipment Part 1: General requirements for safety Section 2.32 Specification for associated equipment of X-ray equipment
EN 60601-2-52_2010 Medical electrical equipment Part 2: Particular requirements and basic essential performance for medical beds
EN 60651 Specification for Sound level meters
EN 60730-1  Automatic electrical controls for household and similar use Part 1: General requirements 
EN 61010-1_1993 Safety requirements for electrical equipment for measurements, control, and laboratory use Part 1: General requirements
EN / IEC 61010-1_2001 Safety requirements for electrical equipment for measurements, control, and laboratory use Part 1: General requirements
EN 61010-2-41 Safety requirements for electrical equipment for measurements, control, and laboratory use Part 2-041. Particular requirements for autoclaves using steam for the treatment of medical materials, and for laboratory processes
EN 61010-2-46 Medical electrical equipment Part 2: Particular requirements for safety- Specification for operating tables
EN 61010-2-61 Safety requirements for electrical equipment for measurements, control, and laboratory use Part 2-061. Particular requirements for autoclaves atomic spectrometers with thermal atomization and ionization
EN 61010-2-101 Safety requirements for electrical equipment for measurement, control, and laboratory use--   Part 2-101 : Particular requirements for in vitro diagnostic (IVD) medical equipment
EN 61029-1 Safety of transportable motor-operated tools Part 1: General requirements
EN / IEC 61326-1_1997 Electrical equipment for measurements, control, and laboratory use-- EMC requirements
EN / IEC 61326-1_2006 Electrical equipment for measurements, control, and laboratory use-- EMC requirements
EN 61326-2-2 Electrical equipment for measurements, control, and laboratory use-- EMC requirements, part 2-2 in low-voltage distribution systems
IEC 34-1 Rotating electrical machines Part 1: Rating and performance
IEC 72-1 Dimensions and output series for rotating electrical machines Part 1: Frame numbers 56 to 400 and flange numbers 55 to 1080
IEC 72-2 Dimensions and output series for rotating electrical machines Part 2: Frame numbers 355 to 1000 and flange numbers 1180 to 2360
IEC 336 X-RAY tube assemblies for medical diagnosis-Characteristics of focal spots
IEC-529 CAMAC-Organization of multi-crate systems
IEC 552 Camac-Organization of multi-crate systems Specification of the branch-highway and Camac crate controller Type A1
IEC 601-1/Amendment 1-2 Medical electrical equipment Part 1: General requirements for safety
IEC 601-1-1 Medical electrical equipment Part 1: General requirements for safety
IEC 601-1-2 Medical electrical equipment Part 1: General requirements for safety 2. Collateral standard: Electromagnetic compatibility--Requirements and tests
IEC 601-1-4 Medical electrical equipment Part 1-4: General requirements for safety-- Collateral standard: Programmable electrical medical systems
IEC 601-2-7 Medical electrical equipment Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators
IEC 601-2-10 Medical electrical equipment Part 2: Particular requirements for the safety of nerve and muscle stimulators
IEC 601-2-14 Medical electrical equipment Part 2: Particular requirements for the safety of electro convulsive therapy equipment
IEC 601-2-22 Medical electrical equipment Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment
IEC 601-2-27 Medical electrical equipment Part 2: Particular requirements for the safety of electrocardiographic monitoring equipment
IEC 711 Particular requirements for hearing aids
IEC 730-2-14 Particular requirements for electric actuators
IEC 788 Medical radiology-Terminology
IEC 804 Integrating-averaging sound level meters
IEC 812 Analysis techniques for system reliability- Procedure for failure mode and effects analysis (FMEA)
IEC 825-1 Safety of laser products Part 1: Equipment classification, requirements and user's guide
IEC 878 Graphical symbols fro electrical equipment in medical practice
IEC 1025 Fault tree analysis (FTA)
IEC 1346-1 Industrial systems, installations and equipments and industrial products-Structuring principles and reference designations Part 1: Basic rules 
IEC 60034-1 Rotating electrical machines-- Part 1: Rating and performance
IEC 60204-1 Safety of machinery-electrical equipment of machines (General requirements)
IEC 60601-1-4:2000 Medical electrical equipment Part 1-4: General requirements for safety-- Collateral standard: Programmable electrical medical systems
IEC 60601-2-2 Medical electrical equipment Part 2-2: Particular requirements for the safety of high frequency surgical equipment
IEC 60601-2-3 Medical electrical equipment Part 2-3: Particular requirements for the safety of short-wave therapy equipment
IEC 60601-2-5 Medical electrical equipment Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment
IEC 60601-2-10 (中譯) Medical electrical equipment Part 2: Particular requirements for the safety of nerve and muscle stimulators
IEC 60601-2-30 Medical electrical equipment Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment
IEC 60601-2-41 Particular requirements for the safety of surgical luminaries and luminaries for diagnosis
IEC 60651 Sound level meters
IEC 60730-1 Automatic electrical controls for household and similar use   Part 1: General requirements
IEC 60730-2-14 Automatic electrical controls for household and similar use   Part 1: Particular requirements for electric actuators
IEC 60825-8 Safety of laser products Part 8: Guidelines for the safe use of medical laser equipment
IEC 60825-9 Safety of laser products Part 9: Compilation of maximum permissible exposure to incoherent optical radiation

註:凡為本會輔導產品相關的標準, 本會都能儘速取得. 

 

bullet電話            886-3-5208829
bulletSkype         ceirs.jen
bulletQQ           2260905240
bullet傳真           886-3-5209783
bullet郵寄地址   新竹市東香里富群街58號
bullet電子郵件   ceirs.jen@msa.hinet.net

 將您的寶貴意見或問題寄到我們的信箱,我們會儘快處理!!                               
上次修改日期: 2013年03月13日