| 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 |
