Third-Party BizVerify
Hefei C&P Nonwoven Products Co., Limited
Verified By : SMR
Verified Date : 2020-10-09

Standard for disposable surgical gown

This standard specifies the requirements, inspection rules, signs, packaging, transportation and storage of disposable surgical gowns (hereinafter referred to as surgical gowns).

1. Requirements

1.1 The basic size of the surgical gown should meet the requirements of Table 1.

Table 1 surgical gown specifications and basic size

Specifications

Length

Width

Belt length

Sleeve length

 

Basic size

Limit deviation

Basic size

Limit deviation

Basic size

Limit deviation

Basic size

Limit deviation

110x130

110

±5

130

±5

170

±5

59

±5

110x142

110

±5

142

±5

170

±5

59

±5

115x135

115

±5

135

±5

170

±5

59

±5

115x140

115

±5

140

±5

170

±5

59

±5

120x140

120

±5

140

±5

180

±5

59

±5

1.2 The disposable surgical gown should be made of non-woven fabric. Non-woven fabrics should comply with FZ/T64005-1996 (thin non-woven fabrics for sanitation).

1.3 PH value (PH value) 5.4 ~ 7.6

1.4 Appearance

1.4.1 The surgical gown is flat. No holes, stains or splicing are allowed.

1.4.2 The sewing needle thread is uniform and straight, with no less than 3 stitches per centimeter.

1.4.3 There are no burrs or missing seams in the sewing area.

1.4.4 The minimum package should be sealed, airtight and able to withstand normal transportation and storage.

1.5 The hygienic index of surgical gown conforms to the regulations on general grade of surgical gown in GB15979-2002 (hygienic standard for disposable sanitary products)

2. Inspection rules

2.1 Surgical gowns must be inspected by the technical supervision department of the factory and submitted for acceptance after being qualified.

2.2 Surgical gowns must be submitted for inspection in batches. Inspections are divided into batch-by-batch inspections and periodic inspections.

2.2.1 Batch by batch inspection

The main sampling type is one-time sampling, and the sampling plan strictly starts from the normal sampling plan.

2.2.2 Periodic inspection

Before the periodic inspection, batch-by-batch inspection should be carried out, and samples should be taken from the batches qualified for batch-by-batch inspection for periodic inspection. If the periodic inspection is qualified, it must be that all the test groups in this cycle are qualified, otherwise the periodic inspection is unqualified.

3. Packaging, marking, transportation, storage

3.1 Packaging

1). Single surgical gown is packed with polyethylene paper-plastic composite bag.

2). The packaging of surgical gown is packed in carton or polyethylene;

3). The sterile surgical gowns are packed in corrugated boxes.

3.2 Logo

3.2.1 The following signs should be on the packaging of the surgical gown:

1). Name and address of the manufacturer;

2). Product name, trademark;

3). Product registration number, hygiene license;

4). Instructions for use;

5). Specifications and quantity;

6). Production lot number or production date;

7). This standard number;

8). Expiry date;

9). One-time sanitary use sign.

3.2.2 There should be an inspection certificate in the middle package, and the following marks should be on the inspection certificate:

1). The name of the manufacturer;

2). Product name;

3). Date of inspection;

4). Inspector code;

3.2.3 Large packaging carton, the following signs should be on the carton:

1). Name and address of the manufacturer;

2). Product name, trademark;

3). Product registration number, hygiene license;

4). Specifications and quantity;

5). Net weight and gross weight;

6). Volume (length x width x height)

7). Date of appearance or batch number;

8). "Fear of rain" and other pictorial signs of storage and transportation;

9). Product standard number.

3.3 Transportation

The transportation requirements are in accordance with the order contract, but it should be protected from rain and moisture during transportation, and be handled with care.

3.4 Storage

Surgical gowns should be stored in a ventilated room where the relative humidity does not exceed 80% and the temperature is between 5 and 55 degrees Celsius, without corrosive gases.

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