|
US$284.00 ยท In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 0869.2-2016: Medical devices. Hierarchical coding structure for adverse events. Part 2: Evaluation codes
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0869.2-2016 | English | 284 |
Add to Cart
|
3 days [Need to translate]
|
Medical devices. Hierarchical coding structure for adverse events. Part 2: Evaluation codes
| Valid |
YY/T 0869.2-2016
|
PDF similar to YY/T 0869.2-2016
Basic data | Standard ID | YY/T 0869.2-2016 (YY/T0869.2-2016) | | Description (Translated English) | Medical devices. Hierarchical coding structure for adverse events. Part 2: Evaluation codes | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C30 | | Classification of International Standard | 03.120.10; 11.040.01 | | Word Count Estimation | 15,193 | | Date of Issue | 2016-01-26 | | Date of Implementation | 2017-01-01 | | Older Standard (superseded by this standard) | YY/T 0869-2013 | | Adopted Standard | ISO/TS 19218-2-2012, IDT | | Regulation (derived from) | China Food and Drug Administration Bulletin 2016 No.25 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the characteristics of the analysis or evaluation of adverse events in medical devices that specify the hierarchical coding structure requirements. These codes are expected to be used primarily by medical device manufacturers and regulators. Coding is used not only for failures that may result in death or serious injury, but also for the analysis or evaluation of events other than death or serious injury. This standard is not intended to determine whether an incident needs to be reported. | YY/T 0869.2-2016: Medical devices. Hierarchical coding structure for adverse events. Part 2: Evaluation codes
---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Medical devices.Hierarchical coding structure for adverse events.Part 2. Evaluation codes
ICS 03.120.10; 11.040.01
C30
People's Republic of China Pharmaceutical Industry Standard
Part of the replacement YY/T 0869-2013
Classification of Medical Device Adverse Event
Part 2. Evaluation code
Medicaldevices-Hierarchicalcoding structures foradverseevents-
Part 2. Evaluationcodes
(ISO /T S19218-2..2012, IDT)
2016-01-26 release
2017-01-01 Implementation
State Food and Drug Administration issued
Directory
Preface I
Introduction II
1 Scope 1
2 terms and definitions
3 Adverse Event Evaluation Code Requirements 1
4 Adverse Event Evaluation Code 2
Appendix A (informative) Encoding system structure 10
Reference 11
Foreword
YY/T 0869 "Medical device adverse event classification coding structure", by the following components.
Part 1. Event type encoding;
Part 2. Evaluation code.
This part is part 2 of YY/T 0869.
This part is drafted in accordance with the rules given in GB/T 1.1-2009.
This part together with YY/T 0869.1-2016 instead of YY/T 0869-2013 "medical device adverse event type and cause of the series
Code structure ", this part and YY/T 0869-2013 compared to the main changes are as follows.
--- modified the "preface";
--- modified "Introduction";
- the terms "permanent damage" and "permanent damage" are removed;
- the term "intended use" has been added;
--- delete the "bad event type code" and "bad event cause coding" two parts;
--- increased the "adverse event evaluation code requirements" and "adverse event evaluation code" two parts;
--- Appendix A is modified to "Coding System Structure";
- "Appendix B encoding example" was deleted;
--- modified the "reference".
This part uses the translation method equivalent to ISO /T S19218-2..2012 "Medical device adverse event classification coding structure Part 2
Points. evaluation code "(English version).
Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents.
This section is proposed by the State Food and Drug Administration.
This part of the National Medical Device Quality Management and General Requirements Standardization Technical Committee (SAC/TC221) centralized.
This part of the drafting unit. Beijing Guoya Huaguang Certification Co., Ltd.
This part of the main drafters. Milan British, Zheng Yi Han, Chen Zhigang.
This part of the partial replacement of the standard version of the previous release.
--- YY/T 0869-2013.
Introduction
The design of the adverse events as specified in this part of YY/T 0869 is mainly due to the manufacturer of the related equipment. Through this
Part of the provided structure, adverse event evaluations can be used to collect postmarketing stages of medical device supervision information. Use a common code that is easy to use
International exchange of information.
This part of YY/T 0869 can be used by health care providers and other users of the device. However, some evaluation code description
The characteristics of the analysis or survey results carried out by the manufacturer or the regulatory authority. Manufacturers or regulators may use adverse events in the following areas
Evaluation code.
- Identify or investigate adverse events with globally recognized evaluation codes, and
- Apply these codes as part of the medical device monitoring or reporting system.
Appendix A shows how to combine bad event coding with other data elements to facilitate global data exchange between regulators.
Classification of Medical Device Adverse Event
Part 2. Evaluation code
1 Scope
This part of YY/T 0869 specifies the classification of the relevant medical device adverse events in the analysis or evaluation results.
Requirements. These codes are expected to be used primarily by medical device manufacturers and regulators. Encoding is not only used to cause death or serious injury
And can also be used to analyze or evaluate the results of events other than death or serious injury.
This section is not intended to determine whether an incident needs to be reported.
2 terms and definitions
The following terms and definitions apply to this document.
2.1
Adverse event
With a medical device that causes the patient, the user or other person to die or cause serious injury, or if the reproduction may result in the patient,
Or other person's death or serious injury.
Note 1. This definition is consistent with the guidelines in GHTF/SG2/N54/R8..2006 [5].
NOTE 2 This definition includes equipment failure or performance degradation that has not caused death or serious injury but may lead to death or serious injury.
Note 3. This definition is not intended to determine whether an event is reported to a regulatory authority.
2.2
Serious injury seriousinjury
Serious deterioration of health conditions includes any of the following.
A life-threatening illness or injury, or
- permanent damage to human body function or permanent damage to human structure, or
- require medical or surgical intervention to prevent permanent damage to human body function or permanent damage to human structure.
Note 1. "permanent" here means irreversible damage or damage, except for minor damage or damage.
Note 2. This definition is consistent with the guidelines in GHTF/SG2/N54/R8..2006 [5].
2.3
Intended use
Expected purpose
An objective description of the manufacturer's use of the product is embodied in the manufacturer's specifications, instructions or information.
Note. This definition is consistent with GHTF/SG1/N41/R9..2005 [6].
3 Adverse Event Evaluation Code Requirements
Adverse event evaluation codes describe the characteristics of adverse event analysis or investigation of the latest conclusions. The code shall be a five-digit number selected from Table 1
code.
Note 1. Multiple coding is necessary to fully evaluate the adverse events.
Note 2. Adverse event evaluation codes are useful for manufacturers and regulators to track reported adverse events. When combined with bad event type encoding,
The characteristics of the adverse events can be conveyed concisely.
Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 0869.2-2016_English be delivered?Answer: Upon your order, we will start to translate YY/T 0869.2-2016_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time. Question 2: Can I share the purchased PDF of YY/T 0869.2-2016_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 0869.2-2016_English will be deemed to be sold to your employer/organization who actually pays 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+ countriesQuestion 4: Do you accept my currency other than USD?Answer: Yes. If you need your currency to be printed on the invoice, please write an email to [email protected]. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.
|