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عنوان استانداردمرجع استاندارد

ISO 13485: 2016Medical devices - Quality management systems - Requirements for

regulatory purpose

ISO 14971:2007Medical devices - Application of risk management to medical devices

ISO 14155:2011Clinical investigation of medical devices for human subjects — Good

clinical practice

IEC 62366-1:2015Medical devices -- Application of usability engineering to medical

devices

EN 1041:2008+A1:2013Information supplied by the manufacturer of medical devices

ISO 15223-1:2016, Corrected version

2017-03

Medical devices — Symbols to be used with medical device labels,

labelling and information to be supplied — Part 1: General

requirements

عنوان استانداردمرجع استانداردنام کاال

گوده آمالگام

ابزار ترمیمی

استانداردهای الزم برای اقالم تولیدی دندانپزشکی

استاندارد

استانداردهای عمومی و کیفی




regulatory purpose



clinical practice




2017-03



ISO 10993-1:2009/Cor 1:2010Biological evaluation of medical devices - Part 1: Evaluation and

testing within a risk management process

ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation

and skin sensitization

ISO 10993-11:2017Biological evaluation of medical devices -- Part 11: Tests for

systemic toxicity

ISO 10993-12:2012Biological evaluation of medical devices -- Part 12: Sample

preparation and reference materials


ISO 21606:2007Dentistry -- Elastomeric auxiliaries for use in orthodonticsبند ارتودنسی

ISO 21606:2007Dentistry -- Elastomeric auxiliaries for use in orthodonticsبندهای االستیك

ISO 21606:2007Dentistry -- Elastomeric auxiliaries for use in orthodontics

ISO 27020 First edition 2010-12-15Dentistry - Brackets and Tubes for use in Orthodontics

ANSI ADA Standard No.100-2012Orthodontic Brackets and Tubes

ISO 21606:2007Dentistry -- Elastomeric auxiliaries for use in orthodontics

ISO 27020 First edition 2010-12-15Dentistry - Brackets and Tubes for use in Orthodontics

ANSI ADA Standard No.100-2012Orthodontic Brackets and Tubes

تیوپ ارتودنسی

براکت ارتودنسی

ارتودنسی

استاندارد


استاندارد های ارزیابی بیولوژیکی



regulatory purpose



clinical practice


devices



2017-03



requirements


تری قالب گیری

ابزار پروتز دندانپزشکی

استاندارد





regulatory purpose



clinical practice


devices



2017-03



requirements



ISO 10993-5:2009Biological evaluation of medical devices - Part 5: Tests for in vitro

cytotoxicity

ISO 10993-6:2016Biological evaluation of medical devices -- Part 6: Tests for local

effects after implantation




systemic toxicity




ISO 14801:2016Dentistry -- Implants -- Dynamic loading test for endosseous dental

implants

استاندارد



اباتمنت ایمپلنت

پروتز دندانی

ASTM F67 - 13(2017)Standard Specification for Unalloyed Titanium, for Surgical Implant

Applications

ASTM F136 - 13Standard Specification for Wrought Titanium-6Aluminum-

4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant

خمیر پروفیالکسی

ISO 21563:2013Dentistry -- Hydrocolloid impression materialsمواد قالبگیری آلژینات

ISO 3107:2011

ANSI ADA Standard No.30-2013

INSO 11791دندان های مصنوعی برای پروتزهای دندانی-دندانپزشکی

EN 1642:2011Dentistry - Medical devices for dentistry - Dental implants

EN 1641:2009Dentistry. Medical devices for dentistry. Materials

ISO 20795-1:2013Dentistry -- Base polymers -- Part 1: Denture base polymers

ISO 7491:2000Dental materials — Determination of colour stability

ISO 22112:2017Dentistry -- Artificial teeth for dental prostheses

ANSI ADA Standard No.15-2008

(R2013)Artificial Teeth For Dental Prostheses

پین های نگهدارنده دندانی

داخل عاج

دندان مصنوعی


اباتمنت ایمپلنت

Dentistry -- Zinc oxide/eugenol cements and zinc oxide/non-eugenolسمان زینك اکساید اوژنول

cements


عنوان استانداردمرجع استانداردISO 13485: 2016Medical devices - Quality management systems - Requirements for ISO 14971:2007Medical devices - Application of risk management to medical devices ISO 14155:2011Clinical investigation of medical devices for human subjects — Good

IEC 62366-1:2015Medical devices -- Application of usability engineering to medical EN 1041:2008+A1:2013Information supplied by the manufacturer of medical devices

ISO 15223-1:2016, Corrected version Medical devices — Symbols to be used with medical device labels, عنوان استانداردمرجع استانداردنام کاال

ANSI/ADA Standard No. 1Alloy for Dental Amalgam

ISO/TS 17988:2014Dentistry -- Corrosion test methods for dental amalgam

ISO 24234:2015Dentistry -- Dental amalgam

ISO 13897:2018Dentistry -- Dental amalgam reusable mixing-capsulesISO 17730:2014Dentistry -- Fluoride varnishesوارنیش

پانسمان

ترمیمیاستاندارد


کپسول آمالگام




regulatory purpose



clinical practice


devices



2017-03



requirements


سرنگ کارتریج مواد بی حسی

بدون محافظ

سرنگ کارتریج مواد بی حسی با

محافظ سوزن

دهان باز کن

آینه هاشیلدها





ابزار عمومی دندانپزشکی

استاندارد





regulatory purpose



clinical practice

IEC 62366-1:2015Medical devices -- Application of usability engineering to medical devices

EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices


2017-03


labelling and information to be supplied — Part 1: General requirements

EN 556-1:2001/AC:2006

Sterilization of medical devices - Requirements for medical devices to be

designated "STERILE" - Part 1: Requirements for terminally sterilized

medical devices

ISO 11607-1:2006/Amd 1:2014Packaging for terminally sterilized medical devices -- Part 1: Requirements

for materials, sterile barrier systems and packaging systems

ISO 11607-2:2006/Amd 1:2014Packaging for terminally sterilized medical devices -- Part 2: Validation

requirements for forming, sealing and assembly processes

ISO 11737-1:2018Sterilization of health care products - Microbiological methods - Part 1:

Determination of the population of microorganisms on product

ISO 11137-1:2006

Sterilization of health care products -- Radiation -- Part 1: Requirements for

development, validation and routine control of a sterilization process for

medical devices

ISO 11137-2:2013Sterilization of health care products -- Radiation -- Part 2: Establishing the

sterilization dose


در )استاندارد های استریلیزاسیون

صورتی که وسیله استریل

(.تولید شود

جراحی دندانپزشکی

استاندارد



ISO 10993-5:2009Biological evaluation of medical devices - Part 5: Tests for in vitro

cytotoxicity

ISO 10993-6:2016Biological evaluation of medical devices -- Part 6: Tests for local

effects after implantation




systemic toxicity




ISO 14801:2016Dentistry -- Implants -- Dynamic loading test for endosseous dental implants

ASTM F136 - 13Standard Specification for Unalloyed Titanium, for Surgical Implant

Applications

ASTM F67 - 13(2017) Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI

(Extra Low Interstitial) Alloy for Surgical Implant Applications

فیکسچر



ISO 13485: 2016Medical devices - Quality management systems - Requirements for regulatory purpose


ISO 14155:2011Clinical investigation of medical devices for human subjects — Good clinical practice



ISO 15223-1:2016, Corrected version 2017-03Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied

— Part 1: General requirements

IEC 60601-1:2005+AMD1:2012 Medical Electrical Equipment- Part 1: General requirements for basic

safety and essential performance

IEC 60601-1-2:2014Medical electrical equipment — Part 1-2: General requirements for basic safety and essential performance

— Collateral Standard: Electromagnetic disturbances — Requirements and tests

IEC 62304:2006/Amd 1:2015Medical device software -- Software life cycle processes


IEC 60601-2-65:2012+AMD1:2017Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential

performance of dental intra-oral-X-ray equipment

AS 3201.5-1977Approval and test specification for electromedical equipment - Part 5 - Dental and mobile medical x-ray

machines

EN 60601-2-28:20170

IEC 60601-2-28:2017

تصویربرداری دندانپزشکی

نام کاالاستاندارد

استانداردهای

اختصاصی

استانداردهای عمومی

استاندارد عمومی


استاندارد

استانداردهای عمومی تجهیزات پزشکی الکتریکی

به جز تجهیزات آزمایشگاهی

دستگاه پری اپیکال دی سی

Medical electrical equipment — Part 2-28: Particular requirements for the basic safety and essential

performance of X-ray tube assemblies for medical diagnosis


ISO 13485: 2016Medical devices - Quality management systems - Requirements for regulatory purpose

ISO 14971: 2007Medical devices - Application of risk management to medical devices

ISO 14155:2011Clinical investigation of medical devices for human subjects — Good clinical practice



ISO 15223-1:2016, Corrected version 2017-03Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied

— Part 1: General requirements

IEC 60601-1:2005+AMD1:2012 Medical Electrical Equipment- Part 1: General requirements for basic

safety and essential performance

IEC 60601-1-2:2014Medical electrical equipment — Part 1-2: General requirements for basic safety and essential performance

— Collateral Standard: Electromagnetic disturbances — Requirements and tests

IEC 62304:2006/Amd 1:2015Medical device software -- Software life cycle processes


INSO 13491-1 الزامات عمومي و روشهاي آزمون-1قسمت-يونيت هاي دندانپزشكي -دندانپزشكي

INSO 3804 صندلي بيمار-دندانپزشكي

INSO 3805چراغ دندانپزشكي

INSO 3806يونيت دندان پزشكي

ISO 7494-1 Second edition 2011-08-15Dentistry - Dental units - Part 1: General requirements and test methods

ISO 7494-2 Second edition 2015-04-01Dentistry - Dental units - Part 2: Air, water, suction and waste water system

ISO 10637:1999Dental equipment -- High- and medium-volume suction systems

ISO 9168 Third edition 2009-07-15Dentistry - Hose connectors for air driven dental handpieces

ISO 6875:2011Dentistry -- Patient chair

ISO 9680:2014Dentistry -- Operating lights

ISO/TS 11080:2009Dentistry -- Essential characteristics of test methods for the evaluation of treatment methods intended to

improve or maintain the microbiological quality of dental unit procedural water

عمومی دندانپزشکی

نام کاالاستاندارد



اختصاصی

استاندارد

استانداردهاي عمومي تجهيزات پزشكي الكتريكي

به جز تجهيزات آزمايشگاهي

دستگاه يونيت دندانپزشكي


استانداردهاي عمومي و کيفي

ISO/TS 22595-1:2006Dentistry -- Plant area equipment -- Part 1: Suction systems

ISO 11143:2008Dentistry -- Amalgam separators

ISO 14457 :2017Dentistry - Handpieces and motors

ISO 3964:2016Dental handpieces -- Coupling dimensions

EN 1639:2009Dentistry. Medical devices for dentistry. Instruments

ISO 9168:2009Dentistry -- Hose connectors for air driven dental handpieces

ISO 14937:2009 Sterilization of health care products -- General requirements for characterization of a sterilizing agent and the

development, validation and routine control of a sterilization process for medical devices

INSO 4860 مقررات عمومي- تجهيزات سترون کننده و ضد عفوني کننده وسايل پزشكي

IEC 61010-2-40:2015Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-40:

Particular requirements for sterilizers and washer-disinfectors used to treat medical materials

ANSI/AAMI ST55:2010 / (R)2014Table-top steam sterilizers

EN 13060:2014Small steam sterilizers

ISO 17665-1:2006Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and

routine control of a sterilization process for medical devices

ISO 14937:2009 Sterilization of health care products -- General requirements for characterization of a sterilizing agent and the

development, validation and routine control of a sterilization process for medical devices

INSO 4860 مقررات عمومي- تجهيزات سترون کننده و ضد عفوني کننده وسايل پزشكي

IEC 61010-2-40:2015Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-40:

Particular requirements for sterilizers and washer-disinfectors used to treat medical materials

ISO/TS 15883-5:2005Washer-disinfectors -- Part 5: Test soils and methods for demonstrating cleaning efficacy

ISO 15883-2:2006Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection

for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.


دستگاه توربيناختصاصی

دستگاه آمالگام سپريتور

دستگاه اتوکالو روميزي

دستگاه اولتراسونيك کلينر

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