What a Complete Compression Stocking Order Must State
A hospital requisition or outpatient prescription for compression hosiery often reaches the purchasing desk as a short note such as "compression stockings, Class II" or "20–30 mmHg below-knee". Neither note is enough to pick a SKU. A stocking can be checked at goods-in, matched to a formulary line and issued against an order only when three groups of fields travel together on the order document.
The first group is the labeled pressure, stated in the label system of the market the item is bought in. US garments are labeled in millimeter-of-mercury (mmHg) ranges such as 15–20 or 20–30 mmHg. German garments that carry the RAL quality mark are labeled by compression class (CCL I to CCL IV) under RAL-GZ 387/1. UK Drug Tariff hosiery can be labeled by British Standard BS 6612:1985 class (Class 1 to Class 3), and RAL-classified garments are also prescribable there. The same class number carries a different pressure range in each system, so an order that gives a class number without naming the system cannot be matched to a physical SKU.
The second group is the measured size, taken from the wearer's leg and read against a named manufacturer's size chart. Sigvaris's US measuring guidance uses the ankle at its thinnest point, the calf at its thickest point and calf length from the floor to the bend of the knee, measured as soon as possible after waking. Shoe size can also appear in a chart, but it does not replace the leg measurements. The order should therefore carry the measurements, the date they were taken and the chart that turned them into a size code.
The third group is category, regulatory identity and billing. The order should say whether the item is an anti-embolism stocking or a graduated medical compression stocking. In the United States, a medical support stocking intended to prevent pooling of blood in the leg is a Class II device under 21 CFR 880.5780(a), exempt from 510(k) premarket notification subject to 21 CFR 880.9, and FDA lists it under product code DWL. For outpatient billing, HCPCS Level II codes bind garment length and mmHg band into one code. The same label-first method runs through our guides to specifying wound dressings by FDA identification and checking surgical skin marker labels before switching SKUs.
Pressure Labels Are Market-Specific: mmHg Ranges, RAL Classes, British Standard Classes
Compression stockings apply their highest pressure at the ankle and less pressure further up the leg. medi states that the pressure around the ankle is decisive for class assignment and that pressure must decrease continuously from ankle to thigh. How that ankle pressure is rated and printed on the package differs by market, so buyers sourcing across distribution networks need to read each market's own label system rather than a single blended scale.
In the United States, garments are labeled in mmHg ranges rather than class numbers. Sigvaris's US guidance lists bands of 8–15, 15–20, 20–30, 30–40 and 40–50 mmHg, describes over-the-counter items as usually around 15–20 mmHg, and calls 20–30 mmHg the level doctors most commonly prescribe. On dispensing, Sigvaris states that by law no prescription is required, but most pharmacies won't dispense higher-level compression (which it describes as roughly 20–30 to 30–40 mmHg) without one, and that a trained and certified fitter should take the measurements. That describes US pharmacy practice, not a federal dispensing rule, and it does not transfer to other markets.
In Germany, medical compression stockings that carry the RAL quality mark are tested against RAL-GZ 387/1, whose requirements are set by the Gütezeichengemeinschaft Medizinische Kompressionsstrümpfe e.V. (GZG), the association that administers the mark. Testing laboratories such as the Hohenstein Institute test the compression effect of stockings to RAL-GZ 387/1 (with 387/2 for arm sleeves and 387/3 for leg-ulcer hosiery systems) and medical compression hosiery to DIN 58133. medi's class overview gives the four compression classes (CCL) by ankle pressure: CCL I 18–21 mmHg (2.4–2.8 kPa), CCL II 23–32 mmHg (3.1–4.3 kPa), CCL III 34–46 mmHg (4.5–6.1 kPa) and CCL IV more than 49 mmHg (more than 6.5 kPa). In this system the doctor specifies the compression class on the prescription, and medi notes that insurance coverage depends on meeting the quality-mark criteria.
In the United Kingdom, the Derbyshire Joint Area Prescribing Committee guideline (local NHS guidance, reviewed September 2025) lists the British Standard BS 6612:1985 Drug Tariff classes as Class 1 (14–17 mmHg at the ankle), Class 2 (18–24 mmHg) and Class 3 (25–35 mmHg). It also notes that RAL-classified garments are prescribable and that a RAL class runs higher than the same-numbered British Standard class. Because both systems can be prescribed, a UK order record should capture whether its class number refers to BS 6612 or RAL, not just the number.
Table 1: Each market's own pressure labels, shown side by side without conversion
| Market and label system | Labeled class or band | Published ankle pressure | Where the range comes from | Who sets the level on the order |
|---|---|---|---|---|
| United States (mmHg band) | 8–15 mmHg | 8–15 mmHg | Manufacturer labeling (Sigvaris US); 21 CFR 880.5780 sets no mmHg values | No prescription required by law |
| United States (mmHg band) | 15–20 mmHg | 15–20 mmHg | Manufacturer labeling (Sigvaris US); 21 CFR 880.5780 sets no mmHg values | Typical over-the-counter level |
| United States (mmHg band) | 20–30 mmHg | 20–30 mmHg | Manufacturer labeling (Sigvaris US); 21 CFR 880.5780 sets no mmHg values | Most commonly prescribed; most pharmacies ask for a prescription |
| United States (mmHg band) | 30–40 mmHg | 30–40 mmHg | Manufacturer labeling (Sigvaris US); 21 CFR 880.5780 sets no mmHg values | Most pharmacies ask for a prescription; certified fitter measures |
| United States (mmHg band) | 40–50 mmHg | 40–50 mmHg | Manufacturer labeling (Sigvaris US); 21 CFR 880.5780 sets no mmHg values | Prescriber specifies |
| Germany (RAL class) | CCL I | 18–21 mmHg (2.4–2.8 kPa) | RAL-GZ 387/1 (GZG quality mark); ranges as published by medi | Doctor specifies the class on the prescription |
| Germany (RAL class) | CCL II | 23–32 mmHg (3.1–4.3 kPa) | RAL-GZ 387/1 (GZG quality mark); ranges as published by medi | Doctor specifies the class on the prescription |
| Germany (RAL class) | CCL III | 34–46 mmHg (4.5–6.1 kPa) | RAL-GZ 387/1 (GZG quality mark); ranges as published by medi | Doctor specifies the class on the prescription |
| Germany (RAL class) | CCL IV | >49 mmHg (>6.5 kPa) | RAL-GZ 387/1 (GZG quality mark); ranges as published by medi | Doctor specifies the class on the prescription |
| United Kingdom (BS Drug Tariff class) | Class 1 | 14–17 mmHg | BS 6612:1985, as listed in Derbyshire JAPC guidance | Prescribable on FP10; RAL garments also prescribable |
| United Kingdom (BS Drug Tariff class) | Class 2 | 18–24 mmHg | BS 6612:1985, as listed in Derbyshire JAPC guidance | Prescribable on FP10; RAL garments also prescribable |
| United Kingdom (BS Drug Tariff class) | Class 3 | 25–35 mmHg | BS 6612:1985, as listed in Derbyshire JAPC guidance | Prescribable on FP10; RAL garments also prescribable |
Anti-Embolism Stockings Are a Different Labeled Category
A common receiving error is treating anti-embolism stockings and graduated medical compression stockings as interchangeable. Both are knitted elastic hosiery, but they are labeled with different pressure profiles for different users, and in the UK they reach patients through different supply routes.
Anti-embolism stockings are labeled for hospitalized, immobilized patients. Cardinal Health describes its T.E.D. anti-embolism stockings as applying a graduated pressure pattern of 18 mmHg at the ankle, 14 mmHg at the calf, 8 mmHg at the popliteal area, 10 mmHg at the lower thigh and 8 mmHg at the upper thigh, and cites clinical study in hospitalized patients for DVT-risk reduction and blood-flow velocity. Cardinal also states that the patient's leg must be measured so the appropriate pressure pattern is applied, so this hospital category needs a measured size on the order too. Manufacturers do not describe the category in identical terms, so record the pressure profile and intended user printed on the label you receive rather than a generic description.
Graduated medical compression stockings are the ambulatory category, labeled in the mmHg bands or classes shown in Table 1—from 15–20 up to 40–50 mmHg in the US, or CCL I to CCL IV under RAL. Because the two categories carry different labeled profiles and intended users, swapping one for the other is a change of product, not just a change of supplier, and it needs the prescriber's authorization like any other pressure change.
The division also shows up in supply routing. The Derbyshire JAPC guideline states that anti-embolism (TED) stockings are not available on FP10 primary-care prescription: they are hospital products for immobilised patients, supplied through community nursing where needed, and flight socks are excluded as well. An FP10-route order that names an anti-embolism product should therefore be queried before it is filled.
In the United States, 21 CFR 880.5780 splits the same elastic construction into two branches by intended use. Under paragraph (a), a medical support stocking intended to prevent pooling of blood in the leg is Class II (special controls) and exempt from 510(k) premarket notification subject to the limitations in 21 CFR 880.9; FDA's classification database lists it as product code DWL, "stocking, medical support (to prevent pooling of blood in legs)". Under paragraph (b), a medical support stocking intended for other medical purposes is Class I, also 510(k)-exempt, and exempt from the part 820 quality management system requirements except those for records and complaint files. Because neither branch needs a 510(k), there is usually no clearance letter to rely on; the device label and the manufacturer's FDA listing, plus the GUDID record where one exists, are what the receiving team can check. Our guide to UDI and GUDID capture for medical consumables covers the label fields to record.
Table 2: Anti-embolism vs graduated medical compression stockings, by what the label says
| Field | Anti-embolism stockings (e.g., T.E.D.) | Graduated medical compression stockings |
|---|---|---|
| Labeled user | Hospitalized, immobilized patients (Cardinal; Derbyshire JAPC) | Ambulatory wearers, at the level the prescriber chose |
| Labeled ankle pressure | About 18 mmHg on the T.E.D. profile | Band or class from Table 1 (15–20 to 40–50 mmHg in the US; CCL I–IV under RAL) |
| Published pressure profile | 18 mmHg ankle, 14 calf, 8 popliteal, 10 lower thigh, 8 upper thigh (Cardinal T.E.D.) | Decreases continuously from ankle to thigh (medi); Lozo et al. note reductions of up to about 80% toward the crotch |
| Size basis | Leg measured so the pressure pattern applies (Cardinal) | Ankle and calf measurements on the maker's size chart (Sigvaris) |
| US regulatory branch to check | 21 CFR 880.5780(a), Class II, product code DWL, when labeled to prevent blood pooling | 880.5780(a) or (b), depending on the labeled intended use; both 510(k)-exempt |
| UK primary-care route | Not on FP10; supplied through hospital and community nursing | Prescribable on FP10 under BS 6612 or RAL classification |
Size Comes from Measured Leg Dimensions, Not Shoe Size Alone
A frequent intake error is treating compression stocking size like a clothing size (Small, Medium, Large) or a shoe size. Sigvaris notes that shoe size is usually one factor in its charts, alongside ankle and calf measurements; shoe size alone cannot produce a size code. The nominal band on the box holds only when the measured leg falls inside the chart range for that size code, and the same labeled stocking delivers different pressure on legs of different dimensions.
The measurement record should capture the points the manufacturer's chart uses. Sigvaris's US guidance names three for below-knee garments:
Ankle circumference: at the thinnest point of the ankle.
Calf circumference: at the thickest point of the calf.
Calf length: from the floor to the right-angle bend of the knee, measured sitting.
Thigh-length and pantyhose styles: the additional thigh and length points defined on that manufacturer's chart. Record them exactly as the chart labels them rather than converting between brands.
Timing and who measures: Sigvaris advises taking measurements as soon as possible after waking, when swelling is at a minimum, and says a trained and certified fitter should measure for prescription levels. In UK primary care, the Derbyshire guideline notes that size need not appear on the prescription because trained community pharmacists measure and fit. Either way, the order record should hold the measured values, the measurement date, who measured, and which manufacturer chart produced the size code.
Standard or made-to-measure: the Derbyshire guideline says standard sizes fit about 95% of cases and reserves made-to-measure garments for legs whose measurements, checked within the last six months, fall outside standard sizes. That gives the order a simple flag—standard or made-to-measure—plus a measurement date the receiving team can check. Dimensional matching matters here for the same reason it does in other sized consumables, such as IV cannula gauge and length specifications: a label code is only meaningful against the measurement it was chosen for.
Wear Period Is Not Expiry
Receiving and inventory staff sometimes look for a sterile expiry date on compression hosiery cartons and, finding none, guess at a rotation rule. That mixes up two different clocks. Unless the label makes a sterility claim, there is no sterile-barrier expiry to rotate against; what limits a compression garment in use is its wear period—how long it keeps its compression while being worn and washed.
Useful wear life: the Derbyshire guideline states that, cared for according to the manufacturer's instructions, garments last three to six months, so two garments per limb cover about six months, with a review every six months. medi frames its own medical stockings as remaining fully effective "until they are replaced in six months' time". Both figures are guideline and manufacturer statements, not measured fleet data, and actual life varies with how often a garment is worn and washed.
For procurement, the two-garments-per-limb pattern becomes a quantity field: under the Derbyshire guideline, an order covering about six months for one limb normally means two garments. Recording that period and quantity on the order makes the next replacement predictable without treating it as stock expiry.
Damage ends the wear period early: the Derbyshire guideline says hosiery with ladders or holes should be discarded. A replacement triggered by damage is a wear event, not an inventory expiry, and should be recorded that way.
Stock date versus in-service date: keep two dates apart in the item master and the patient-supply record. Whatever storage or shelf-life statement the manufacturer prints on the carton governs unissued stock; the sources behind this guide give no general shelf life for unworn garments, so ask the supplier for it in writing rather than assuming one. The three-to-six-month wear period is a separate clock tied to wearing and washing, so record the issue date and plan replacement from that date.
The Order Record: A Prescription-to-SKU Label Check
To reduce dispensing errors and claim rejections, purchasing and receiving teams can check each order in a fixed sequence that compares the ordered fields with the physical label.
flowchart TD
A["Order received: compression stockings"] --> B{"Which label system does the order name?"}
B -->|"US"| C["mmHg band, e.g. 20-30 mmHg"]
B -->|"Germany / RAL"| D["RAL class CCL I to IV"]
B -->|"UK Drug Tariff"| E["BS 6612 class 1 to 3"]
B -->|"None stated"| Q["Return order for clarification"]
C --> F{"Which category was ordered?"}
D --> F
E --> F
F -->|"Anti-embolism"| G["Match labeled profile and intended user"]
F -->|"Graduated medical compression"| H["Match band or class in the same system"]
G --> I["Check measured ankle, calf and length against the named size chart"]
H --> I
I --> K{"Inside a standard size range?"}
K -->|"Yes"| L["Standard SKU: record size code and chart"]
K -->|"No"| M["Made-to-measure: record measurement date"]
L --> N["Record issue date and 3-6 month wear period, separate from stock date"]
M --> NUS HCPCS coding: for US outpatient claims, CMS-maintained HCPCS Level II codes for compression garments sit in the A6501–A6614 range. The AAPC/Codify listing gives A6531 as "Gradient compression stocking, below knee, 30-40 mmhg, used as a surgical dressing, each". The code binds the length (below knee) and the mmHg band (30–40) together, so an order record that gives a length without a band, or a band without a length, cannot be coded. Confirm the current-year descriptor against the CMS HCPCS file before using a code for billing; coverage rules are payer policy and outside this guide.
EU MDR identity: seleon's regulatory analysis treats medical compression stockings as Class I medical devices under the EU MDR that must carry a CE mark unless custom-made, and notes that materials such as nanomaterials, silver additives or pharmaceuticals can raise the classification to Class IIa, IIb or III regardless of the intended use. For a garment with such additives, ask the supplier which class it claims and for the conformity evidence behind that claim, rather than assuming Class I.
Table 3: Prescription-to-SKU label check for hospital buyers
| Order field | What the order must state | Where to read it | Evidence to file |
|---|---|---|---|
| Pressure and label system | mmHg band (US), RAL CCL class or BS 6612 class, with the system named | Package label and garment label | RAL quality-mark or test evidence for RAL claims; otherwise the manufacturer's published pressure statement |
| Category | Anti-embolism or graduated medical compression | Product description and intended-use statement on the package or instructions | Labeled intended user; FDA product code DWL where the stocking is labeled to prevent blood pooling |
| Length and style | Below knee, thigh length or pantyhose; open or closed toe | Package description and catalog SKU description | Manufacturer specification sheet; HCPCS length descriptor for US claims |
| Size code | Manufacturer size code, flagged standard or made-to-measure | Package label | The named size chart with ankle and calf ranges for that code |
| Measurement record | Ankle, calf and length values, measurement date, who measured | Not on the SKU: order attachment or fitting record | Fitting record; Derbyshire uses a six-month freshness check for made-to-measure decisions |
| Regulatory identity | US: 21 CFR 880.5780 branch (Class II DWL or Class I); EU: CE-marked MDR class | Manufacturer details and CE marking on the package | FDA listing and GUDID record where available; supplier's MDR class statement |
| Billing code (US) | HCPCS Level II code matching length and band, e.g. A6531 for below knee 30–40 mmHg | Item master and invoice, not the garment | Current CMS HCPCS descriptor |
| Wear period | Replacement interval in months and garments per limb | Care and use instructions | Manufacturer care and replacement statement; local guideline (e.g., three to six months) |
Vendor RFQ Checklist: Five Questions to Ask
When tendering or qualifying a new compression hosiery supplier, ask these five questions and keep the answers with the item master:
Pressure standard: Under which system is each SKU's pressure labeled (US mmHg band, RAL-GZ 387/1 class, BS 6612:1985 class or the manufacturer's own method), and what ankle pressure range is claimed?
Category and intended user: Is the SKU labeled as an anti-embolism stocking for immobilized patients or as a graduated medical compression stocking for ambulatory use?
Size chart: Will the supplier provide the size chart with minimum and maximum ankle and calf circumferences (and length points) for every standard size code, plus its made-to-measure process?
Regulatory identity and additives: Which 21 CFR 880.5780 branch and FDA product code apply in the US, which MDR class and CE marking apply in the EU, and does the textile contain additives such as silver that change the classification?
Wear period and care: What replacement interval does the manufacturer state, under which washing instructions, and what storage or shelf-life statement applies to unissued stock?
Sources
21 CFR 880.5780 - Medical support stocking. Legal Information Institute, Cornell Law School (mirror of the official CFR). Classification of medical support stockings: Class II for preventing blood pooling, Class I for other medical purposes, both 510(k)-exempt.
FDA Product Classification - DWL, stocking, medical support (to prevent pooling of blood in legs). U.S. Food and Drug Administration classification database: regulation 880.5780, Class 2, 510(k) exempt, General Hospital panel.
Compression levels and when to wear which one (Sigvaris US). SIGVARIS GROUP (manufacturer). US mmHg pressure bands, US dispensing practice and measuring points.
What are the compression classes for compression stockings? (medi FAQ). medi GmbH & Co. KG (manufacturer). RAL compression classes CCL I–IV with ankle pressure in mmHg and kPa; the doctor specifies the class.
T.E.D. Anti-Embolism Stockings (Cardinal Health). Cardinal Health (manufacturer). Labeled T.E.D. graduated pressure profile and hospital-patient context.
Guideline for the use of compression hosiery in Primary Care (Derbyshire JAPC). Derbyshire Joint Area Prescribing Committee (local NHS guidance), reviewed September 2025. BS 6612:1985 Drug Tariff classes, RAL prescribing, anti-embolism supply route, fitting and three-to-six-month useful life.
HCPCS code A6531 - Gradient compression stocking, below knee, 30-40 mmHg, used as a surgical dressing. AAPC / Codify mirror of CMS-maintained HCPCS Level II descriptors (compression garments range A6501–A6614); confirm against the current CMS file.
Testing medical compression textiles - RAL-GZ 387 and DIN 58133. Hohenstein Institute (testing laboratory). Testing of compression effect to RAL-GZ 387/1, /2 and /3 and DIN 58133.
Gütezeichengemeinschaft Medizinische Kompressionsstrümpfe e.V. - Home. The German quality-mark association that administers the RAL quality mark for medical compression stockings.
The MDR requirements for medical devices also apply to compression stockings (seleon). seleon GmbH (regulatory consultancy), 2020/2022. EU MDR Class I status, CE marking and class escalation for additives.
The Structure and Compression of Medical Compression Stockings (Materials, 2022). Lozo, Penava, Lovričević and Vrljičak. Materials (MDPI), 2022, 15(1):353. Laboratory study of stocking compression on leg models and comparison of national class norms.
Taking care of compression stockings - how do you wash them correctly? (medi FAQ). medi GmbH & Co. KG (manufacturer). Washing guidance, elasticity recovery and six-month replacement framing.
