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ISO 國際標準
ISO R594 Conical fittings for syringes, needles and other medical equipment
ISO 594/1 Conical fittings with a 6% (Luer) taper for syringes, needles and other medical equipment-- Part 1: General requirements
ISO 594-2 Conical fittings with a 6% (Luer) taper for syringes, needles and other medical equipment-- Part 2: Lock fittings
ISO 780 Packaging-Pictorial marking for handling of goods
ISO 1219 Fluid power systems and components-Graphic symbols
ISO 1797-1: 1992

Dental rotary instruments--Shanks       Part 1: Shanks made of metals

ISO 2859-0 Sampling procedures for inspection by attributes Part 0: Introduction to the ISO 2859 attribute sampling system
ISO 2859-1 Sampling procedures for inspection by attributes Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection
ISO 2859-2 Sampling procedures for inspection by attributes Part 2: Sampling plans indexed by limiting quality (LQ) for isolated lot inspection
ISO 2859-3 Sampling procedures for inspection by attributes Part 3: Skip-lot sampling procedures
ISO 2859-4 Sampling procedures for inspection by attributes Part 4: Procedures for assessment of stated quality levels
ISO 3040 Technical drawings--Dimensioning and tolerancing-- Cones
ISO 3696 Water for analytical laboratory use--Specification and test methods
ISO 3746 Acoustics-Determination of sound power levels of noise sources using sound
ISO 3964 Dental handpieces - Coupling dimensions
ISO 5356-1 Anesthetic and respiratory equipment-Conical connectors Part 1: cones and sockets
ISO 5367 Breathing tubes intended for use with anaesthetic apparatus and ventilators
ISO 5457 Technical drawings-Sizes and layout of drawing sheets
ISO 5725-2 Accuracy of measurement methods and results, Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method
ISO 5941 Compressors, pneumatic tools and machines--Preferred pressures
ISO 6009 Hypodermic needles for single use--Color coding for identification
ISO 6360-1 Dental rotary instruments- Number coding system Part 1: General characteristics
ISO 6440 Wheelchairs-Nomenclature, terms and definitions
ISO 6710 Single-use containers for venous blood specimen collection
ISO 7000 Graphical symbols for use on equipment-Index and synopsis
ISO 7176-1 Wheelchairs-- Part 1: Determination of static stability
ISO 7176-2 Wheelchairs-- Part 2: Determination of dynamic stability of electric wheelchairs
ISO 7176-3 Wheelchairs-- Part 3: Determination of efficiency of brakes
ISO 7176-4 Wheelchairs-- Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range
ISO 7176-5 Wheelchairs-- Part 5: Determination of overall dimensions, mass and turning space
ISO 7176-6 Wheelchairs-- Part 6: Determination of maximum speed, acceleration and retardation of electric wheelchairs
ISO 7176-7 Wheelchairs-- Part 7: Measurement of seating and wheel dimensions
ISO 7176-8 Wheelchairs-- Part 8: Requirements and test methods for static, impact and fatigue strengths
ISO 7176-9 Wheelchairs-- Part 9: Climatic tests for electric wheelchairs
ISO 7176-10 Wheelchairs-- Part 10: Determination of obstacle-climbing ability of electric wheelchairs
ISO 7176-11 Wheelchairs-- Part 10: Determination of obstacle-climbing ability of electric wheelchairs
ISO 7176-13 Wheelchairs--Part 13: Determination of coefficient of friction of test surfaces
ISO 7176-14 Wheelchairs--Part 14: Power and control systems for electric wheelchairs- Requirements and test methods
ISO 7176-15 Wheelchairs-- Part 15: Requirements for information disclosure, documentation and libeling
ISO 7176-16 Wheelchairs-- Part 16: Resistance to ignition of upholstered parts-- Requirements and test methods
ISO 7176-19 Wheelchairs-- Part 19: Wheeled mobility devices for use in motor vehicles
ISO 7176-22 Wheelchairs-- Part 22: Set-up procedures
ISO 7176-23 Wheelchairs-- Part 23: Requirements and test methods for attendant-operated stair-climbing devices
ISO 7376-1 Laryngoscopic fittings-- Part 1: Conventional hook-on type handle-blade fittings
ISO 7376-2 Laryngoscopic fittings-- Part 2: Miniature electric lamps--Screw threads and sockets for conventional blades
ISO 7376-3 Laryngoscopic fittings-- Part 3: Fiber-illuminated re-usable rigid laryngoscopes
ISO 7193 Wheelchairs-Maximum overall dimensions
ISO 7711-1 Dental rotary instruments- Diamond instruments Part 1: Dimensions, requirements, marking and packaging
ISO 7864 Sterile hypodermic needles for single use
ISO 7785-1: 1997 Dental handpieces-- Part 1: High-speed air turbine handpieces
ISO 7785-2 Dental handpieces-- Part 2: Straight and geared angle handpieces
ISO 7886-1 Sterile hypodermic needles for single use Part 1: Syringes for manual use
ISO 7886-2 Sterile hypodermic needles for single use Part 2: Syringes for use with power-driven syringe pumps
ISO 7930 Wheelchairs--Type classification based on appearance characteristics
ISO 8320 Optics and optical instruments--contact lenses--vocabulary and symbols
ISO 8320-1 Contact lenses and conact lens care products--Vocabulary   Part 1: Contact lenses
ISO 8320-2 Contact lenses and conact lens care products--Vocabulary   Part 2: Contact lens care products
ISO 8321-1 Optics and optical instruments--contact lenses Part 1: specification for rigid corneal and sclera contact lenses
ISO 8321-2 Optics and optical instruments--contact lenses Part 2: Specifications for single-vision hydrogen contact lenses 
ISO 8382 Resuscitators intended for use with humans
ISO 8536-1 Infusion equipment for medical use-- Part 1 : Infusion glass bottles
ISO 8536-2 Infusion equipment for medical use-- Part 2 : Closures for infusion bottles
ISO 8536-3 Infusion equipment for medical use-- Part 3 : Aluminium caps for infusion bottles
ISO 8536-4 Infusion equipment for medical use-- Part 4 : Infusion sets for single use, gravity feed
ISO 8536-5 Infusion equipment for medical use-- Part 5 :  Burette type infusion sets
ISO 8536-6 Infusion equipment for medical use-- Part 6 :  Freeze drying closures for infusion bottles
ISO 8536-7 Infusion equipment for medical use-- Part 7 :  Caps made of aluminium--plastics combinations for infusion bottles
ISO 8537 Sterile single-use syringes, with or without needle, for insulin
ISO 8599 Optics and optical instruments--Contact lenses-Determination of the spectral and luminous transmittance
ISO 8601 Data elements and interchange formats--Information interchange--representation of dates and times
ISO 8980-1 Ophthalmic optics--finished single-vision corrective lenses-- Part 1: General requirements
ISO 8980-2 Ophthalmic optics-- Uncut finished spectacle lenses Part 2: Specifications for progressive power lenses
ISO 9000 Quality management systems- Fundamentals and vocabulary
ISO 9000-4 Quality management and quality assurance standards-
ISO 9001 Quality management systems- Requirements
ISO 9004 Quality management systems - Guidelines for performance improvements
ISO 9004-1 Quality management and quality system elements-- Part 1: Guidelines
ISO 9004-2 Quality management and quality system elements-- Part 2: Guidelines for services
ISO 9004-3 Quality management and quality system elements-- Part 3: Guidelines for processed materials
ISO 9004-4 Quality management and quality system elements-- Part 4: Guidelines for quality improvement
ISO 9168: 1991 Dental handpieces-- Hose connectors
ISO 9336-1 Optics and optical instruments--Optical transfer function--application Part 1: Interchangeable lenses for 35mm still cameras
ISO 9336-2 Optics and optical instruments--Optical transfer function--application Part 2: Lenses for office copiers
ISO 9336-3 Optics and optical instruments--Optical transfer function--application Part 3: Telescopes
ISO 9338 Optics and optical instruments-contact lenses-determination of the diameters
ISO 9339-1 Optics and optical instruments-contact lenses-determination of the thickness Part 1: rigid contact lenses
ISO 9340 Optics and optical instruments-contact lenses-determination of strains for rigid contact lenses
ISO 9341 Optics and optical instruments-contact lenses-determination of inclusions and surface imperfections for rigid contact lenses
ISO 9342 Optics and optical instruments--Test lenses for calibration of foci meters
ISO 9360-1 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 250ml
ISO 9360-2 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 250ml
ISO 9363-1 Optics and optical instruments--Contact lenses- Determination of cytotoxicity of contact lens material
ISO 9614-1 Acoustics-Determination of sound power levels of noise sources using sound.  Part 1: Measurement at discrete points 
ISO 9626 Stainless steel needle tubing for manufacture of medical devices
ISO 9680 Dental operating light
ISO 9687 Dental equipment-- Graphical symbols
ISO 9913-1 Optics and optical instruments- contact lenses Part 1: Determination of oxygen permeability and transmissibility by the FATT method
ISO 9914 Optics and optical instruments- contact lenses-- Determination of refractive index of contact lens materials
ISO 9919 Medical electrical equipment--Particular requirements for the basic safety and essential performance pulse oximeters requirement for medical use
ISO 9999 Technical aids for disabled persons Classification
ISO 10005 Quality management- Guidelines for quality plans
ISO 10006 Quality management- Guidelines to quality in project management
ISO 10007 Quality management- Guidelines for configuration management
ISO 10012-1 Quality assurance requirements for measuring equipment Part 1: Metrological confirmation system for measuring equipment
ISO 10012-2 Quality assurance requirements for measuring equipment Part 2: Guidelines for control of measurement processes
ISO 10013 Guidelines for developing quality manuals
ISO 10014 Guidelines for managing the economics of quality
ISO 10015 Quality management- Guidelines for training
ISO 10017 Guidance on statistical techniques for ISO 9001:1994
ISO 10079-1 Medical suction equipment Part 1: electrically powered suction equipment--Safety requirements
ISO 10079-2 Medical suction equipment Part 2: Manually powered suction equipment
ISO 10079-3 Medical suction equipment Part 3: Suction equipment powered from vacuum or pressure source
ISO 10338 Optics and optical instruments- contact lenses- determination of curvature
ISO 10339 Ophthalmic optics--contact lenses--Determination of water content of hydrogel lenses
ISO 10322-1 Ophthalmic optics--Semi-finished lens blanks Part 1: specifications for single-vision and multifocal lens blanks
ISO 10340 Optics and optical instruments- contact lenses-- Method for determining the extractable substances
ISO 10344 Optics and optical instruments- contact lenses- saline solution for contact lens testing
ISO 10555-1:1995 Sterile, single use Intravascular Catheters; Part 1: General requirements
ISO 10555-1:2009 Sterile, single use Intravascular Catheters; Part 1: General requirements
ISO 10555-2:1996 Sterile, single use Intravascular Catheters; Part 2: Angiographic catheters
ISO 10555-3:1996 Sterile, single use Intravascular Catheters; Part 3: Central venous catheters
ISO 10555-4:1996 Sterile, single use Intravascular Catheters; Part 3: Balloon dilatation catheters
ISO 10555-5:1996 Sterile, single use Intravascular Catheters; Part 3: Over-needle peripheral catheters
ISO 10725 General requirements for the competence of testing and calibration laboratories
ISO 10993-1 Biological evaluation of medical devices- Part 1: evaluation and testing
ISO 10993-3 Biological evaluation of medical devices- Part 3: test for genotoxicity carcinogenicity and reproductive toxicity
ISO 10993-4 Biological evaluation of medical devices- Part 4: Selection of tests for interactions with blood.
ISO 10993-5 Biological evaluation of medical devices- Part 5: test for in vitro cytotoxicity
ISO 10993-7 Biological evaluation of medical devices- Part 7: Ethylene oxide sterilization residuals
ISO 10993-10 Biological evaluation of medical devices- Part 10: Tests for irritation and delayed-type hypersensitivity
ISO 10993-11 Biological evaluation of medical devices- Part 11: Tests for systemic toxicity
ISO 11134 Sterilization of health care products--Requirements for validation and routine control-- Industrial moist heat sterilization
ISO 11135 Medical devices--Validation and routine control of ethylene oxide sterilization
ISO 11137 Sterilization of health care products--Requirements for validation and routine control--Radiation sterilization
ISO 11137-1: 2006 Sterilization of health care products--Requirements for validation and routine control--Radiation sterilization
ISO 11137-2: 2006 Sterilization of health care products--Radiation--Establishing the sterilization dose
ISO 11137-3: 2006 Sterilization of health care products--Radiation-- Guidance for dosimetric aspects
ISO 11199-1 Walking aids manipulated by both arms-- Requirements and test methods---  Part 1: Walking frames
ISO 11199-2 Walking aids manipulated by both arms-- Requirements and test methods---  Part 2: Rollator
ISO 11987 Ophthalmic optics--contact lenses--Determination of shelf-life
ISO 12864 Ophthalmic optics-- contact lenses- determination of scattered light
ISO 13402 Surgical and dental hand instruments--Determination of resistance against autoclaving, corrosion and thermal exposure
ISO 13485 Quality systems- Medical devices- Particular requirements for the application of ISO 9001
ISO13485 ( 2000 : Draft ) Quality management systems- Medical devices- System requirements for regulatory purposes
ISO13485 ( 2003/07/15 ) Medical devices--Quality management systems--Requirements for regulatory purposes
ISO 14001 Environmental management systems--Specification with guidance for use
ISO 14155 Clinical investigation of medical devices
ISO 14534 Ophthalmic optics-Contact lenses and contact lens care products-fundamental requirements
ISO 14602 Non-active surgical implants---Implants for Osteosynthesis Particular requirements
ISO 14630 Non-active surgical implants---General requirements
ISO 14889 Ophthalmic optics-Spectacle lenses-Fundamental requirements for uncut finished lenses
ISO 14969 Quality systems-Medical devices- Guidance on the application of ISO 13485 and ISO 13488
ISO 14971: 2003 Medical devices---Application of risk management to medical devices
ISO 14971: 2007 Medical devices---Application of risk management to medical devices
ISO 15197 In vitro diagnostic test systems-- Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
ISO 15223-1: 2008 Medical devices-- Symbols to be used with medical device labels, labeling and information to be supplied
ISO 15606: 1999 Dental handpieces-- Air-powered scalers and scaler tips
ISO / TS 16949 Particular requirements for the application of ISO 9001: 2000 for automotive production and relevant service part organizations
ISO 17025 General requirements for the competence of testing and calibration laboratories
ISO 17511 In vitro diagnostic medical devices-- Measurement of quantities in biological samples -- Metrological traceability of values assigned to calibrators and control materials
ISO 17664 Sterilization of medical devices-- Information to be provided by the manufacturer for the processing of resterilizable medical devices
ISO 17665-1 Sterilization of health care products-- part 1: validation and control of sterilization process for medical devices
ISO 17799 Information technology-Code of practice for information security management
ISO 19011 Guidelines for quality and/or environmental management systems auditing
ISO 20225:2001 (GMDN) Global Medical Device Nomenclature for the purpose of regulatory data exchange
ISO 21647 Medical electrical equipment--Particular requirements for the basic safety and essential performance of respiratory gas monitors
ISO 22000 Food safety management systems-- Requirements for any organization in the food chain
ISO 22716 Cosmetics-- Guideline on Good Manufacturing Practices
ISO 27001 Internal Information Security Management System

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