YY 0285.3-2017 PDF English
US$145.00 · In stock · Download in 9 secondsYY 0285.3-2017: [Including 2019XG1] Intravascular catheters - Sterile and single-use catheters - Part 3: Central venous catheters Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedureStatus: Valid YY 0285.3: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| YY 0285.3-2017 | English | 145 |
Add to Cart
|
0-9 seconds. Auto-delivery
|
[Including 2019XG1] Intravascular catheters - Sterile and single-use catheters - Part 3: Central venous catheters
| Valid |
| YY 0285.3-1999 | English | 314 |
Add to Cart
|
3 days
|
Sterile, single-use intravasoular catheters. Part 3: Central venous catheters
| Obsolete |
Excerpted PDFs (Download full copy in 9 seconds upon purchase)PDF Preview: YY 0285.3-2017
YY 0285.3-2017: [Including 2019XG1] Intravascular catheters - Sterile and single-use catheters - Part 3: Central venous catheters ---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/YY0285.3-2017
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.20
C 31
Replacing YY 0285.3-1999
Intravascular catheters - Sterile and single-use
catheters - Part 3. Central venous catheter
(ISO 10555-3.2013, Intravascular catheters - Sterile and single-use catheters
- Part 3. Central venous catheters, MOD)
Issued on: JULY 17, 2017
Implemented on: SEPTEMBER 1, 2019
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 5
2 Normative references ... 5
3 Terms and definitions ... 5
4 Requirements ... 5
Foreword
YY 0285 "Intravascular catheters - Sterile and single-use catheters" consists of
four parts.
- Part 1. General requirements;
- Part 3. Central venous catheters;
- Part 4. Balloon dilatation catheters;
- Part 5. Over-needle peripheral catheters.
This Part is Part 3 of YY 0285.
This Part was drafted in accordance with the rules given in GB/T 1.1-2009.
This Part replaces YY 0285.3-1999 "Sterile single-use intravascular catheters -
Part 3. Central venous catheters". Compared with YY 0285.3-1999, the main
technical changes are as follows.
- updated the normative references;
- deleted Annex A.
This Part uses redrafting method to modify and adopt ISO 10555-3.2013
"Intravascular catheters - Sterile and single-use catheters - Part 3. Central
venous catheters".
The technical differences and reasons between this Part and ISO 10555-3.2013
are as follows.
- about normative references, this Standard made an adjustment on
technical differences so as to adapt to the technical conditions in China;
see Clause 2 "Normative references" for the adjustment, as follows.
● replaced ISO 10555-1.2013 with YY 0285.1-2017 that modified and
adopted the International standard.
Attention is drawn to the possibility that some of the elements of this document
may be the subject of patent rights. The issuing authority shall not be held
responsible for identifying any or all such patent rights.
This Part was proposed by China Food and Drug Administration.
This Part shall be under the jurisdiction of National Technical Committee on
Medical Infusion Apparatus of China (SAC/TC 106).
Intravascular catheters - Sterile and single-use
catheters - Part 3. Central venous catheter
1 Scope
This Part specifies the requirements for sterile and single-use central venous
catheter.
2 Normative references
The following referenced documents are indispensable for the application of
this document. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any
amendments) applies.
YY 0285.1-2017, Intravascular catheters - Sterile and single-use catheters -
Part 1. General requirements (ISO 10555-1.2013, MOD)
3 Terms and definitions
For the purposes of this document, the terms and definitions defined in YY
0285.1-2017 and the followings apply.
3.1 central venous catheter
a central venous system is inserted for intravascular catheters for the delivery
of fluids or blood samples and/or for pressure or other measurements, and is
divided into single chambers or multiple chambers
NOTE The catheter may have a fixation system as an integral part of the instrument.
4 Requirements
4.1 General
The catheter shall comply with the requirements of YY 0285.1-2017 except for
peak tension (see YY 0285.1-2017, 4.6). The peak tension shall meet the
requirements of 4.4.
4.2 Distance mark
...... Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
Tips & Frequently Asked QuestionsQuestion 1: How long will the true-PDF of English version of YY 0285.3-2017 be delivered?Answer: The full copy PDF of English version of YY 0285.3-2017 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 0285.3-2017_English with my colleagues?Answer: Yes. The purchased PDF of YY 0285.3-2017_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+ countriesQuestion 4: Do you accept my currency other than USD?Answer: Yes. www.ChineseStandard.us -- YY 0285.3-2017 -- 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. Question 5: Should I purchase the latest version YY 0285.3-2017?Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY 0285.3-2017 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically.
How to buy and download a true PDF of English version of YY 0285.3-2017?A step-by-step guide to download PDF of YY 0285.3-2017_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 0285.3-2017". 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
|