HOME   Cart(0)   Quotation   About-Us Policy PDFs Standard-List
www.ChineseStandard.net Database: 189760 (18 Oct 2025)

YY 0709-2009 PDF English

US$485.00 · In stock · Download in 9 seconds
YY 0709-2009: Medical electrical equipment. Part 1-8: General requirements for safety. Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure
Status: Obsolete
Standard IDContents [version]USDSTEP2[PDF] deliveryName of Chinese StandardStatus
YY 0709-2009English485 Add to Cart 0-9 seconds. Auto-delivery Medical electrical equipment. Part 1-8: General requirements for safety. Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems Obsolete

Excerpted PDFs (Download full copy in 9 seconds upon purchase)

PDF Preview: YY 0709-2009
      

Similar standards

YY/T 0664   YY/T 0618   YY/T 0616.1   YY/T 0916.7   

YY 0709-2009: Medical electrical equipment. Part 1-8: General requirements for safety. Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems



---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YY0709-2009
PHARMACEUTICAL INDUSTRY STANDARD ICS 11.040.01 C 30 YY 0709-2009 / IEC 60601-1-8.2003 Replacing YY 0574.1~0574.3-2005 Medical Device Software – Part 1-8.General Requirements for Safety – Collateral Standard. General Requirements, Tests and Guidance for Alarm Systems in Medical Electrical Equipment and Medical Electrical Systems (IEC 60601-1-8.2003, IDT) Issued on. NOVEMBER 25, 2009 Implemented on. DECEMBER 01, 2010 Issued by. China Food and Drug Administration

Table of Contents

Foreword... 3 SECTION ONE – GENERAL... 5 1 * Scope and Object... 5 2 Terminology and Definitions... 7 6 Identification, Marking and Documents... 12 SECTION TWO TO TEN – NOT USED... 13 201 Alarm Systems... 13 Annexes... 33 Appendix D (Normative) Symbols on Marking... 33 Annex AAA (Informative) Rationale and Guidance... 38 Annex BBB (Informative) Cross-Reference of Identification, Marking, and Documents... 79 Annex CCC (Informative) Guidance for Auditory Alarm Signals... 83 Annex DDD (Informative) Verbal Alarm Signals... 85 Annex EEE (Normative) * Reserved Melodies for Alarm Signals... 88 Bibliography... 89

Foreword

All technical contents of this collateral standard are mandatory. The serial standards on the safety of Medical Electrical Equipment consist of the following two Parts. --- Part 1.General Requirements for Safety; --- Part 2.Particular Requirements for Safety. Thereof, the Part 1 also includes other standards besides this collateral standard. --- GB 9706.1 Medical Electrical Equipment--Part 1.General Requirements for Safety; --- YY 0505 Medical Electrical Equipment－Part 1-2.General Requirements for Safety－Collateral Standards. Electromagnetic Compatibility－Requirements and Tests; --- GB 9706.12 Medical Electrical Equipment - Part 1.General Requirements for Safety 3.Collateral Standard. General Requirements for Radiation Protection in Diagnostic X-Ray Equipment; --- GB 9706.15 Medical Electrical Equipment - Part 1.General Requirements for Safety - 1.Collateral Standard. Safety Requirements for Medical Electrical Systems. This collateral standard belongs to Part 1-8 of Medical Electrical Equipment. This collateral standard replaced the following standards. YY 0574.1-2005 Anaesthesia and Respiratory Care Alarm Signals - Part 1.Visual Alarm Signals, YY 0574.2-2005 Anaesthesia and Respiratory Care Alarm Signals- Part 2.Auditory Alarm Signal, YY 0574.3-2005 Anaesthesia and Respiratory Care Alarm Signals - Part 3. Guidance on Application of Alarm. This Standard equivalently adopts IEC 60601-1-8.2003 Medical Electrical Equipment – Part 1-8.General Requirements for Safety – Collateral Standard. General Requirements, Tests and Guidance for Alarm Systems in Medical Electrical Equipment and Medical Electrical Systems. The major differences between this collateral standard and IEC 60601-1-8 are as follows. --- For other international standards referenced in this Standard, if they have been converted into Chinese Standard, this collateral standard shall replace the referenced international standards number with the corresponding national standard number; --- Delete the index of the term definitions; --- Terms are indicated in bold in the text. This collateral standard’s Annexes, D and EEE are normative; while the Annexes AAA, BBB, CCC, DDD are informative. This collateral standard shall be under the jurisdiction of National Technical Committee for Standardization of Medical Electrical Equipment (SAC/TC 10). Drafting staff of this collateral standard. Shanghai Testing & Inspection Institute for Medical Devices. Chief drafting staff of this collateral standard. He Jun. Medical Device Software – Part 1-8.General Requirements for Safety – Collateral Standard. General Requirements, Tests and Guidance for Alarm Systems in Medical Electrical Equipment and Medical Electrical Systems SECTION ONE – GENERAL 1 Scope and Object The object of this collateral standard is to specify basic safety and essential performance requirements and tests for ALARM SYSTEMS in MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS and to provide guidance for their application. This is accomplished by defining alarm categories (priorities) by degree of urgency, consistent ALARM SIGNALS and consistent control states and their marking for all ALARM SYSTEMS.

2 Terminology and Definitions

For the purposes of this collateral standard, the following definitions apply. 4) NOTE. This collateral standard uses the term “equipment” to mean MEDICAL ELECTRICAL EQUIPMENT or non-MEDICAL ELECTRICAL EQUIPMENT in the context of a MEDICAL ELECTRICAL SYSTEM.

6 Identification, Marking and Documents

Additional requirements for the marking on controls and instruments are specified in this collateral standard, together with the technical requirements, giving rise to requirements on markings. These requirements are also listed in BBB.1.

201 Alarm Systems

Each ALARM CONDITION shall cause the generation of visual ALARM SIGNALS as specified in this collateral standard. If deemed necessary by risk assessment regarding the environment in which the ALARM SYSTEM is intended to be used, additional ALARM SIGNALS shall be generated. ......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.


      

Tips & Frequently Asked Questions

Question 1: How long will the true-PDF of English version of YY 0709-2009 be delivered?

Answer: The full copy PDF of English version of YY 0709-2009 can be downloaded in 9 seconds, and it will also be emailed to you in 9 seconds (double mechanisms to ensure the delivery reliably), with PDF-invoice.

Question 2: Can I share the purchased PDF of YY 0709-2009_English with my colleagues?

Answer: Yes. The purchased PDF of YY 0709-2009_English will be deemed to be sold to your employer/organization who actually paid for it, including your colleagues and your employer's intranet.

Question 3: Does the price include tax/VAT?

Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countries

Question 4: Do you accept my currency other than USD?

Answer: Yes. www.ChineseStandard.us -- YY 0709-2009 -- Click this link and select your country/currency to pay, the exact amount in your currency will be printed on the invoice. Full PDF will also be downloaded/emailed in 9 seconds.

How to buy and download a true PDF of English version of YY 0709-2009?

A step-by-step guide to download PDF of YY 0709-2009_EnglishStep 1: Visit website https://www.ChineseStandard.net (Pay in USD), or https://www.ChineseStandard.us (Pay in any currencies such as Euro, KRW, JPY, AUD).
Step 2: Search keyword "YY 0709-2009".
Step 3: Click "Add to Cart". If multiple PDFs are required, repeat steps 2 and 3 to add up to 12 PDFs to cart.
Step 4: Select payment option (Via payment agents Stripe or PayPal).
Step 5: Customize Tax Invoice -- Fill up your email etc.
Step 6: Click "Checkout".
Step 7: Make payment by credit card, PayPal, Google Pay etc. After the payment is completed and in 9 seconds, you will receive 2 emails attached with the purchased PDFs and PDF-invoice, respectively.
Step 8: Optional -- Go to download PDF.
Step 9: Optional -- Click Open/Download PDF to download PDFs and invoice.
See screenshots for above steps: Steps 1~3    Steps 4~6    Step 7    Step 8    Step 9